Generated by All in One SEO v4.9.10, this is an llms.txt file, used by LLMs to index the site.

# Boyds

A global drug development consultancy helping to translate ideas into medicinal products and treatments for the benefit of patients.

## Sitemaps

- [XML Sitemap](https://boydconsultants.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Achieving FDA and EMA alignment for a first-in-class gene therapy program](https://boydconsultants.com/achieving-fda-and-ema-alignment-for-a-first-in-class-gene-therapy-program/) - A gene therapy company was working with Boyds on the regulatory strategy for their first in-class treatment for a rare disease that included a complex, novel delivery device and sought Boyds’ advice on how best to gain global regulatory feedback and alignment on their planned pivotal trial.
- [From FDA Approval to EU Marketing Authorisation: Transforming Module 3 for EMA Submission](https://boydconsultants.com/from-fda-approval-to-eu-marketing-authorisation-transforming-module-3-for-ema-submission/) - An FDA-approved Module 3 is not automatically suitable for European submission. Discover how Boyds helped a biotech company identify critical CMC gaps, align its dossier with EMA expectations, and successfully support EU marketing authorisation.
- [Boyds sponsors London Life Sciences Week 2026](https://boydconsultants.com/boyds-sponsors-london-life-sciences-week-2026/) - Boyds is pleased to announce sponsorship of London Life Sciences Week 2026, which takes place from 15-20 November 2026.
- [Boyds appoints Laurence Skillern as Chief Medical Officer](https://boydconsultants.com/boyds-appoints-laurence-skillern-as-chief-medical-officer/) - Boyds has strengthened its Clinical Operations team with the appointment of Sharon Mitchell as Clinical Project Manager, supporting the consultancy’s continued growth and expanding portfolio of client projects.
- [Boyds earns Bronze Medal from EcoVadis for sustainability performance](https://boydconsultants.com/boyds-earns-bronze-medal-from-ecovadis-for-sustainability-performance/) - Boyds has been awarded a Bronze Medal by EcoVadis, a global leader in business sustainability assessments.
- [Katherine Bowen recognised as a Fellow of TOPRA](https://boydconsultants.com/katherine-bowen-recognised-as-a-fellow-of-topra/) - Katherine Bowen, Chief Regulatory Affairs Officer at Boyds, has been awarded Fellow of TOPRA, the highest grade of membership offered by the professional body.
- [Boyds appoints Sharon Mitchell as Clinical Project Manager to support growth in clinical operations](https://boydconsultants.com/boyds-appoints-sharon-mitchell-as-clinical-project-manager-to-support-growth-in-clinical-operations/) - Boyds has strengthened its Clinical Operations team with the appointment of Sharon Mitchell as Clinical Project Manager, supporting the consultancy’s continued growth and expanding portfolio of client projects.
- [The FDA’s Manufacturing Flexibilities for Cell and Gene Therapies Guidance – Another Cog in the Nebulous Machine](https://boydconsultants.com/the-fdas-manufacturing-flexibilities-for-cell-and-gene-therapies-guidance-another-cog-in-the-nebulous-machine/) - Boyds Director of Regulatory Affairs, Dr Eric Hardter, dives deep into the FDA's manufacturing flexibilities for cell and gene therapies guidance.
- [Assessment of Development Milestones to Support Further Investment Decisions](https://boydconsultants.com/assessment-of-development-milestones-to-support-further-investment-decisions/) - Boyds undertake a rapid assessment to determine whether contractual development milestones had been achieved, thereby triggering further investment in the target company.
- [Fast Track, Breakthrough Therapy and RMAT: Choosing the Right FDA Expedited Pathway](https://boydconsultants.com/fast-track-breakthrough-therapy-and-rmat-choosing-the-right-fda-expedited-pathway/) - Discover how FDA expedited pathways, including Fast Track, Breakthrough Therapy and RMAT, can support faster and more efficient product development.
- [Supporting the Next Generation of Life Sciences Talent: Leon Larkou’s Perspective on Mentorship with Alan Boyd](https://boydconsultants.com/supporting-the-next-generation-of-life-sciences-talent-leon-larkous-perspective-on-mentorship-with-alan-boyd/) - At Boyds, we believe that supporting the next generation of life sciences professionals is essential to the future of healthcare innovation.
- [Advancing CMC in Accelerated Programs: Insights on the FDA’s CDRP Program](https://boydconsultants.com/advancing-cmc-in-accelerated-programs-insights-on-the-fdas-cdrp-program/) - The FDA launched the CMC Development and Readiness Pilot (CDRP) Program in 2023 as part of PDUFA VII commitments.
- [Product development support to benchmark novel medical food product](https://boydconsultants.com/product-development-support-to-benchmark-novel-medical-food-product/) - The client, an R&D driven FMCG company, approached Boyds to help them better understand how to successfully develop and position their novel medical food product in the market.
- [Strategic Due Diligence Support for Viral Vector Manufacturing Acquisition](https://boydconsultants.com/strategic-due-diligence-support-for-viral-vector-manufacturing-acquisition/) - This case study explores how Boyds supported a UK-US private equity investment bank consortium with detailed technical and commercial due diligence on an EU-based viral vector manufacturing company.
- [For-Cause Due Diligence: Assessing Technical Disclosure in a Medical Device Acquisition](https://boydconsultants.com/for-cause-due-diligence-assessing-technical-disclosure-in-a-medical-device-acquisition/) - When concerns emerged following the acquisition of a medical device company, Boyds was engaged to undertake a retrospective due diligence investigation. By analysing historical technical data, management disclosures, and development timelines, our team uncovered critical programme risks and delays, enabling the client to better understand the true status of the asset and inform strategic decision-making.
- [EU PRIME Scheme for priority medicines](https://boydconsultants.com/eu-prime-scheme-for-priority-medicines/) - PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines targeting unmet medical needs
- [MHRA-UK – The Innovative Licensing and Access Pathway (ILAP)](https://boydconsultants.com/mhra-uk-the-innovative-licensing-and-access-pathway-ilap/) - The ILAP is a program designed to facilitate and accelerate the development of innovative medicines and drug-device combinations.
- [EMA offers Information session on breakthrough medical devices (BtX)](https://boydconsultants.com/ema-offers-information-session-on-breakthrough-medical-devices-btx/) - At end of 2025, the EU Medical Device Coordination Group (MDCG) published a guidance introducing the Breakthrough Devices framework (MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 ).
- [The End-of-Phase 2 Meeting – Potential Drawbacks of Missing the Mark on this Critical Milestone](https://boydconsultants.com/the-end-of-phase-2-meeting-potential-drawbacks-of-missing-the-mark-on-this-critical-milestone/) - This blog, written by Eric Hardter, Director of Regulatory Affairs at Boyds, explores why the End-of-Phase 2 meeting is a critical milestone in drug development.
- [Getting a rare disease phase 3 program back on track through global regulatory alignment](https://boydconsultants.com/getting-a-rare-disease-phase-3-program-back-on-track-through-global-regulatory-alignment/) - A US-based small biotech company approached Boyds as they were about to commence their Phase 3, single pivotal trial in a rare disease for which they had orphan designation.
- [FDA Flexible CMC Requirements for Cell and Gene Therapies: What Sponsors Need to Know](https://boydconsultants.com/fda-flexible-cmc-requirements-for-cell-and-gene-therapies-what-sponsors-need-to-know/) - In this blog, Moira Frances explores the FDA’s January 2026 announcement formalizing a flexible approach to CMC requirements for cell and gene therapies, highlighting the key changes and what they mean for sponsors progressing toward BLA submission.
- [8 Key Takeaways from the FDA’s Workshop on Advancing Pediatric Cell and Gene Therapy Clinical Trials](https://boydconsultants.com/8-key-takeaways-from-the-fdas-workshop-on-advancing-pediatric-cell-and-gene-therapy-clinical-trials/) - The FDA recently held a public webinar on advancing pediatric cell and gene therapy clinical trials. Our Director of Regulatory Affairs, Dr. Eric Hardter, had eight key takeaways from the full-day event.
- [Part 1: Laying the Foundations for a Successful FDA Meeting](https://boydconsultants.com/part-1-navigating-an-fda-meeting-best-practices-for-maximizing-your-time-and-effort/) - Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice to sponsors on conducting an FDA meeting.
- [Part 2: Developing a Strong FDA Meeting Package and Regulatory Strategy](https://boydconsultants.com/part-2-navigating-an-fda-meeting-best-practices-for-maximizing-your-time-and-effort/) - Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice to sponsors on conducting an FDA meeting.
- [Part 3: Ensuring a Productive FDA Meeting and Clear Next Steps](https://boydconsultants.com/part-3-navigating-an-fda-meeting-best-practices-for-maximizing-your-time-and-effort/) - In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance for sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.
- [How Gene Therapy Could Transform Osteoarthritis Treatment](https://boydconsultants.com/how-gene-therapy-could-transform-osteoarthritis-treatment/) - A blog exploring how gene therapy is transforming osteoarthritis treatment based on a recent webinar organised by the International Cartilage Regeneration and Joint Preservation Society (ICRS)
- [Boyds Teams Come Together to Support Local Food Banks](https://boydconsultants.com/boyds-teams-come-together-to-support-local-food-banks/) - Recently, the Boyds team supported local food banks by taking part in a Supermarket Sweep event for charity.
- [Boyds scoop Business of the Year at South Cheshire Chamber Awards](https://boydconsultants.com/boyds-scoop-business-of-the-year-at-south-cheshire-chamber-awards/) - Boyds took away the award for Business of the Year (under 25 employees) at the 2019 South Cheshire Chamber of Commerce Business Awards.
- [Susan Tansey elected as Fellow of the Royal College of Paediatrics and Child Health](https://boydconsultants.com/susan-tansey-fellow-royal-college-paediatrics-child-health/) - Susan Tansey elected as a Fellow of the Royal College of Paediatrics and Child Health.
- [Navigating the complex regulatory landscape of medical devices in the EU](https://boydconsultants.com/navigating-the-complex-regulatory-landscape-of-medical-devices-in-the-eu/) - In this blog, Eamonn McGowran, Associate Director of Regulatory Affairs at Boyds, discusses the changes and key considerations for developers navigating the regulations, especially when managing combination products that integrate both devices and medicinal products.
- [Boyds launches Regulatory Operations service](https://boydconsultants.com/boyds-launches-regulatory-operations-service/) - Boyds are excited to announce the expansion of its service offering with the launch of a new in-house regulatory operations service.
- [Boyds article published by Clinical Leader](https://boydconsultants.com/boyds-article-published-by-clinical-leader/) - An article authored by Dr Harriet Gray Stephens, pharmaceutical physician in Boyds’ clinical and medical affairs team has been featured by Clinical Leader
- [Boyds appoints Neil Chakrabarti as Chief Financial Officer](https://boydconsultants.com/boyds-appoints-neil-chakrabarti-as-chief-financial-officer/) - Boyds welcomes Neil Chakrabarti as Chief Financial Officer, as the company reported a record-breaking 25 percent growth in turnover
- [Clinical Trials with Genetically Modified Organisms (EU)](https://boydconsultants.com/clinical-trials-with-genetically-modified-organisms-eu/) - Investigational medicinal products (IMPs) that contain or consist of genetically modified organisms (GMOs) constitute a special regulatory case.
- [Nitrosamine Impurities: A Persistent Regulatory Challenge in Drug Development](https://boydconsultants.com/nitrosamine-impurities-a-persistent-regulatory-challenge-in-drug-development/) - Explore how FDA and EMA guidance is shaping nitrosamine risk assessments and why robust strategies are essential to avoid major objections in regulatory submissions.
- [Experienced pharmaceutical physician joins Boyds as Medical Director](https://boydconsultants.com/experienced-pharmaceutical-physician-joins-boyds-as-medical-director/) - Drug development consultancy Boyds has appointed Kate Owen as Medical Director in its Medical and Clinical Affairs team.
- [Rare Disease Day 2026: Accelerating Regulatory Innovation for Rare and Ultra-Rare Diseases](https://boydconsultants.com/rare-disease-day-2026/) - Since its creation in 2008, Rare Disease Day is observed every year on February 28th (or 29 February in leap years - the rarest day of the year). The day provides an opportunity to advocate for rare diseases as a human rights priority at local, national, and international levels, promoting a more inclusive society.
- [Professor Alan Boyd receives MBE at investiture ceremony at St James’s Palace](https://boydconsultants.com/professor-alan-boyd-receives-mbe-at-investiture-ceremony-at-st-jamess-palace/) - We are delighted to share that Professor Alan Boyd, Founder and CEO of Boyds, has formally received his MBE at an investiture ceremony held at St James's Palace, following his recognition in The 2026 New Year Honours List.
- [Shifts in FDA Thinking: What a Single‑Trial Pathway Could Mean for Drug Development](https://boydconsultants.com/shifts-in-fda-thinking-what-a-single-trial-pathway-could-mean-for-drug-development/) - The recent NEJM commentary from Drs. Marty Makary and Vinay Prasad hints at a potential shift in FDA expectations - stating that a single well‑designed pivotal trials is now the default position for US approval ending the widely held doctrine that two pivotal trials are generally required.
- [Contracts Administrator joins the Boyds team](https://boydconsultants.com/contracts-administrator-joins-the-boyds-team/) - Drug development consultancy Boyds has announced the appointment of Chloe Evanson as Contracts Administrator.
- [Boyds’ continues support for local community radio station The Cat for another year](https://boydconsultants.com/boyds-continues-support-for-local-community-radio-station-the-cat/) - Boyds, global drug development consultancy headquartered in Crewe, has reaffirmed its commitment to supporting the local community by continuing its patronage of The Cat for a further year.
- [International Day of Women and Girls in Science: Words of Wisdom from Boyds](https://boydconsultants.com/international-day-of-women-and-girls-in-science-words-of-wisdom-from-boyds/) - International Day of Women and Girls in Science is a global movement to recognise the vital role women play across science and to encourage the next generation of girls to see science as a place where they belong.
- [Boyds celebrates 20th anniversary milestone](https://boydconsultants.com/boyds-celebrates-20th-anniversary-milestone/) - Today (17 March 2025) marks the 20th anniversary of Boyds. From humble beginnings to becoming a key player in drug development consultancy, our story is one of innovation and growth, driven by a dedication to improving the lives of patients worldwide.
- [FAST-EU: A New Era for Multinational Clinical Trials in Europe](https://boydconsultants.com/fast-eu-a-new-era-for-multinational-clinical-trials-in-europe/) - In this blog, Shalini Gupta explores the launch of FAST-EU (Facilitating and Accelerating Strategic Clinical Trials in the EU) and what it means for sponsors navigating multinational clinical trials in Europe.
- [Bringing Clarity to ATMP Analytics: The Value of Best Practice Guidance](https://boydconsultants.com/atmp-analytics/) - In this blog, we explore how the British Pharmacopoeia’s ATMP Best Practice Guidance is helping to bring much-needed clarity and consistency to ATMP analytics.
- [Celebrating 20 years at Boyds: Mel Entwisle](https://boydconsultants.com/celebrating-20-years-at-boyds-mel-entwisle/) - This year marks 20 years since Mel Entwisle, Finance Manager at Boyds, joined the company as our first employee.
- [Boyds bolsters Regulatory Affairs team with CMC expertise](https://boydconsultants.com/boyds-bolsters-regulatory-affairs-team-with-cmc-expertise/) - Boyds is pleased to announce the appointment of Moira Francois as Senior Manager, CMC Regulatory Affairs.
- [Three director promotions at Boyds](https://boydconsultants.com/three-director-promotions-at-boyds/) - Boyds has announced three promotions in our Regulatory Affairs and Medical Writing teams.
- [The European Biotech Act: A Turning Point for EU Health Biotechnology](https://boydconsultants.com/the-european-biotech-act-a-turning-point-for-eu-health-biotechnology/) - Kelsey Lenoch explores the European Commission’s adoption of the European Biotech Act on 16 December 2025 and what it signals for the future of biotechnology in the EU.
- [Plain Language Summaries in Clinical Trials: Regulatory Requirements and Best Practice](https://boydconsultants.com/plain-language-summaries-in-clinical-trials/) - Laura Erwin gives guidance on delivering clear, compliant plain language summaries for clinical trials, including regulatory and operational best practices.
- [Meet the Boyds team: Ami Patel PhD](https://boydconsultants.com/meet-the-boyds-team-ami-patel-phd/) - Ami Patel PhD, Senior Director, Business Development & Product Development at Boyds, explains her background and shares insights into industry trends.
- [Professor Alan Boyd awarded MBE and recognised in The 2026 New Year Honours List](https://boydconsultants.com/professor-alan-boyd-awarded-mbe-and-recognised-in-the-new-year-2026-honours-list/) - Professor Alan Boyd has been awarded an MBE and recognised in the King's 2026 New Year Honours list for services to gene therapy and to medical education
- [Individualized Therapies on the Rise: Reflections from the Duke-Margolis/FDA Workshop](https://boydconsultants.com/individualized-therapies-on-the-rise/) - Individualized therapies are reshaping drug development. Insights from the Duke-Margolis/FDA workshop on n-of-1, gene editing, and fit-for-purpose regulation.
- [ICH M4Q(R2): Key Changes to CTD Quality Modules 2.3 and 3](https://boydconsultants.com/ich-m4qr2-key-changes-to-ctd-quality-modules-2-3-and-3/) - An overview of the ICH M4Q(R2) guideline, outlining key structural changes to CTD Quality Modules 2.3 and 3 and implications for future regulatory submissions.
- [Boyds appoints Group IT Manager](https://boydconsultants.com/boyds-appoints-group-it-manager/) - Boyds has announced the appointment of David Rosser as Group IT Manager, based in its Crewe office.
- [Navigating the MHRA’s International Recognition Procedure](https://boydconsultants.com/navigating-the-mhras-international-recognition-procedure/) - Since 1 January 2024, the MHRA has offered drug developers a faster route to market through its International Recognition Procedure (IRP).
- [London Life Sciences Week 2025: highlights and key takeaways](https://boydconsultants.com/london-life-sciences-week-2025-highlights-and-key-takeaways/) - Boyds was delighted to be part of London Life Sciences Week as a proud Bronze sponsor.
- [Delivering a high-priority FDA submission: Regulatory Operations excellence under pressure](https://boydconsultants.com/delivering-a-high-priority-fda-submission-regulatory-operations-excellence-under-pressure/) - Boyds’ Regulatory Operations team partnered with a global healthcare company to deliver a complex, high-priority FDA submission under tight deadlines. This case study highlights how expert planning, eCTD compliance, and seamless collaboration ensured a timely, fully compliant submission — demonstrating regulatory excellence under pressure.
- [How to accelerate regulatory reviews with an eCTD viewer](https://boydconsultants.com/how-to-accelerate-regulatory-reviews-with-an-ectd-viewer/) - Following another successful major filing at Boyds, the benefits of incorporating an eCTD viewer tool into the Quality Control (QC) process are once again evident. In our latest blog from the Regulatory Operations team at Boyds, we outline those advantages and explains how such investment delivers value from the initial to the final review.
- [Boyds appoints Senior Manager of Quality Systems and Quality Assurance](https://boydconsultants.com/boyds-appoints-senior-manager-of-quality-systems-and-quality-assurance/) - We are thrilled to announce the appointment of experienced Quality Assurance professional, Macnish Christian.
- [Latest FDA Regulatory Updates: Leadership, Rare Disease Evidence & New Initiatives](https://boydconsultants.com/latest-fda-regulatory-updates/) - Kelsey Lennoch, Associate Director, Regulatory Affairs at Boyds, explores the latest developments and regulatory updates at the FDA and offers guidance for sponsors, clinicians, and scientists navigating this complex environment.
- [The Regulatory Operations challenge: Avoiding common pitfalls with complex eCTD submissions.](https://boydconsultants.com/the-regulatory-operations-challenge-avoiding-common-pitfalls-with-complex-ectd-submissions/) - This article highlights the pivotal role and systems that a skilled Regulatory Operations function plays during the often time-constrained phases of a project.
- [Pilot of medical device clinical investigation fee waiver program for micro and small sized enterprises](https://boydconsultants.com/pilot-of-medical-device-clinical-investigation-fee-waiver-program-for-micro-and-small-sized-enterprises/) - The MHRA had launched a pilot program offering clinical investigation application fee waivers pilot programme offering clinical investigation application fee waivers to micro and small sized UK enterprises.
- [MHRA publishes rare therapies and UK regulatory considerations](https://boydconsultants.com/mhra-publishes-rare-therapies-and-uk-regulatory-considerations/) - Professor Alan Boyd comments on the MHRA paper announcing its intention to overhaul the rulebook for rare disease therapies in the UK
- [Navigating the FDA Landscape: More Changes, and What's Next?](https://boydconsultants.com/navigating-the-fda-landscape-more-changes-and-whats-next/) - In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions.
- [20 years of innovation: learnings from the evolution of drug development](https://boydconsultants.com/20-years-of-innovation-learnings-from-the-evolution-of-drug-development/) - Professor Alan Boyd, Founder and CEO of Boyds, shares insights and key lessons learnt over the past two decades in the drug development industry.
- [Boyds sponsors London Life Sciences Week 2025](https://boydconsultants.com/boyds-sponsors-london-life-sciences-week-2025/) - Boyds is proud to sponsor London Life Sciences Week 2025, taking place from 11–15 November 2025.
- [Contracts Administrator](https://boydconsultants.com/contracts-administrator/) - Boyds is currently looking for a Contracts Administrator to join our growing life sciences consultancy business based in our Crewe office.
- [Ada Lovelace Day 2025: words of wisdom](https://boydconsultants.com/ada-lovelace-day-2025-words-of-wisdom/) - To mark Ada Lovelace Day 2025, members of the Boyds team share their advice and encouragement for young women aspiring to enter STEM fields.
- [Boyds features in European Pharmaceutical Manufacturer](https://boydconsultants.com/boyds-features-in-european-pharmaceutical-manufacturer/) - An article authored by Boyds has published in the Sep-Oct 2025 issue of European Pharmaceutical Manufacturer.
- [Combined gene therapy expertise supports US biotech](https://boydconsultants.com/combined-gene-therapy-expertise-supports-us-biotech/) - Boyds use gene therapy expertise to support an early-stage start-up at the pre-clinical stage of developing a suite of gene therapy products for a cardiovascular indication.
- [Regulatory support for the development of a stem cell therapy and device for the treatment of Parkinson’s Disease](https://boydconsultants.com/boyds-provides-early-stage-regulatory-services-for-the-development-of-a-stem-cell-therapy-and-device-for-the-treatment-of-parkinsons-disease/) - Boyds provided regulatory support to an academic institution client with an exciting proposal for a first-in-human stem cell therapy trial involving a medical device for the treatment of Parkinson's Disease.
- [Comprehensive regulatory support for a gene therapy BLA submission](https://boydconsultants.com/comprehensive-regulatory-support-for-a-gene-therapy-bla-submission/) - Boyds was engaged by a Finnish biopharmaceutical company to provide regulatory consultancy services for the preparation and submission of a Biologics License Application (BLA submission) for an innovative gene therapy.
- [End-to-end regulatory support for a gene therapy MAA submission](https://boydconsultants.com/end-to-end-regulatory-support-for-a-gene-therapy-maa-submission/) - Boyds was engaged by a US-based biotechnology company to provide regulatory consultancy services for the preparation and submission of a MAA submission for a novel gene therapy in the European Medicines Agency (EMA) region.
- [Celebrating 20 Years of Boyds: Team Offsite at Ansty Hall](https://boydconsultants.com/celebrating-20-years-of-boyds-team-offsite-at-ansty-hall/) - This October, the Boyds team gathered at Ansty Hall in Coventry for a special company offsite to celebrate an incredible milestone - 20 years of Boyds.
- [Guest Blog: My marketing internship experience at Boyds](https://boydconsultants.com/guest-blog-my-marketing-internship-experience-at-boyds/) - Over the past eight weeks, Ege Ulusoy, a master’s student in Digital Marketing at the University of Manchester, has been working with Boyds as a Marketing Intern.
- [Boyds’ Regulatory Affairs team shortlisted in TOPRA Awards 2025](https://boydconsultants.com/boyds-regulatory-affairs-team-shortlisted-in-topra-awards-2025/) - The Regulatory Affairs team at Boyds is delighted to have been shortlisted in the TOPRA Awards for Regulatory Excellence 2025 in the Support category.
- [Expert and swift publishing support for an urgent EU Marketing Authorization Application](https://boydconsultants.com/expert-and-swift-publishing-support-for-an-urgent-eu-marketing-authorization-application/) - Boyds was approached by a biotech to manage the publishing of an EU Marketing Authorization Application (MAA) Submission for a new medicinal product in a very short turn around.
- [What are the EMA’s latest transparency requirements?](https://boydconsultants.com/what-are-the-emas-latest-transparency-requirements/) - During 2024 and 2025, several important updates to EMA transparency policies have come into effect, notably under the EU Clinical Trials Regulation (EU CTR) and the reactivation of Policy 0070. In our latest blog, Senior Regulatory and Medical Writer, Laura Erwin, explains more.
- [Updated regulatory guidance for Digital Mental Health Technologies](https://boydconsultants.com/updated-regulatory-guidance-for-digital-mental-health-technologies/) - Eamonn McGowran, Associate Director, Regulatory Affairs at Boyds explains the updated regulatory guidance for Digital Mental Health Technologies.
- [The FDA CDER/CBER Rare Disease Evidence Principles Approval Process](https://boydconsultants.com/the-fda-cder-cber-rare-disease-evidence-principles-approval-process/) - In a recent communication from the United States Food and Drug Administration’s (US FDA) Rare Disease Innovation Hub1, the general framework of a proposed process for facilitating approval of drugs to treat rare diseases (termed the Rare Disease Evidence Principles, or RDEP) was unveiled.
- [Marketing intern join Boyds](https://boydconsultants.com/marketing-intern-join-boyds/) - Boyds is delighted to welcome digital marketing master’s student Ege Ulusoy as a marketing intern.
- [Boyds welcomes medical intern](https://boydconsultants.com/boyds-welcomes-medical-intern/) - Boyds has welcomed neuroscience master’s student Martha Hill as a medical intern within Boyds’ Clinical and Medical Affairs team.
- [Understanding the shifting US regulatory landscape: insights for drug developers](https://boydconsultants.com/understanding-the-shifting-us-regulatory-landscape-insights-for-drug-developers/) - Boyds’ Dr Katherine Bowen and Dr Eric Hardter provide advice for drug developers navigating the complexities of the regulatory landscape.
- [UK Government Responds to MHRA Consultation on Future Medical Device Regulation](https://boydconsultants.com/uk-government-responds-to-mhra-consultation-on-future-medical-device-regulation/) - MHRA publishes UK government’s response to public consultation on future routes to market for medical devices designed to modernise regulation
- [How to avoid common drug development pitfalls](https://boydconsultants.com/how-to-avoid-common-drug-development-pitfalls/) - Boyds’ Dr Neil Fish and Dr Ami Patel explore the real-world challenges of drug development and provide insights on how to avoid the common pitfalls associated.
- [COMBINE launches “all-in-one” coordinated assessment pilot](https://boydconsultants.com/combine-launches-all-in-one-coordinated-assessment-pilot/) - The first phase of the COMBINE Project 1 pilot has been launched by the European Commission, participating member states, and the European Medicines Agency.
- [EU proposes expert panel for orphan and paediatric devices](https://boydconsultants.com/eu-proposes-expert-panel-for-orphan-and-paediatric-devices/) - The European Commission has announced plans to set up a dedicated expert panel in the field of orphan and paediatric medical devices.
- [Trio of promotions at Boyds](https://boydconsultants.com/trio-of-promotions-at-boyds/) - Boyds is delighted to announce a series of promotions across the company.
- [Boyds joins UK BioIndustry Association](https://boydconsultants.com/boyds-joins-uk-bioindustry-association/) - We’re proud to announce that we’ve joined the BioIndustry Association (BIA), the UK’s leading trade association for the life sciences and biotech sector.
- [FDA publishes roadmap to reducing animal testing in preclinical safety studies](https://boydconsultants.com/fda-publishes-roadmap-to-reducing-animal-testing-in-preclinical-safety-studies/) - The FDA plans to phase out animal testing requirements for the development of monoclonal antibodies and other drugs, and use human-relevant methods instead.
- [Further growth for Boyds’ specialist Regulatory Operations team](https://boydconsultants.com/further-growth-for-boyds-specialist-regulatory-operations-team/) - We are delighted to announce the appointment of Lisa Allenby as Associate Director, Regulatory Operations.
- [Boyds appoints Vice President of Regulatory Affairs](https://boydconsultants.com/boyds-appoints-vice-president-of-regulatory-affairs/) - Global drug development consultancy Boyds has appointed a Vice President of Regulatory Affairs in response to growing demand for its specialist services and expertise.
- [Professor Alan Boyd recognised in The Medicine Maker Power List 2025](https://boydconsultants.com/professor-alan-boyd-recognised-in-the-medicine-maker-power-list-2025/) - Professor Alan Boyd, CEO of Boyds, has once again been recognised in the Advanced Medicine category of The Medicine Maker’s Power List, which celebrates pioneers driving progress and shaping the future of drug development.
- [Clinical Trials in Europe: 10 Essential Tips for US Sponsors](https://boydconsultants.com/clinical-trials-in-europe-10-essential-tips-for-us-sponsors/) - In this expert guide, Chris Moore, Senior Clinical Project Manager at Boyds, shares 10 essential considerations for U.S. biotechs looking to set up successful clinical trials in Europe under the new Clinical Trials Regulation (CTR) and CTIS system.
- [Understanding the aims of the EU COMBINE project](https://boydconsultants.com/understanding-the-aims-of-the-eu-combine-project/) - The European Commission launched the COMBINE project in June 2023
- [Exploring the FDA’s draft guidance on AI in regulatory decision-making](https://boydconsultants.com/exploring-the-fdas-draft-guidance-on-ai-in-regulatory-decision-making/) - The draft guidance offers recommendations on using AI-generated information or data to support regulatory evaluations of safety, effectiveness, or quality.
- [Boyds expands US regulatory affairs team with new hire](https://boydconsultants.com/boyds-expands-us-regulatory-affairs-team-with-new-hire/) - We are delighted to announce the appointment of senior regulatory affairs professional, Kelsey Lenoch.
- [Five top tips for securing marketing authorization in Europe](https://boydconsultants.com/five-top-tips-for-securing-marketing-authorization-in-europe/) - In this blog, Dr Katherine Bowen, Chief Regulatory Affairs Officer at Boyds, provides her top tips for obtaining EU marketing authorization through the centralised procedure.
- [Laura Erwin joins Medical Writing Team](https://boydconsultants.com/laura-erwin-joins-medical-writing-team/) - Boyds has welcomed Laura Erwin as Senior Clinical and Regulatory Medical Writer to the team bolstering Boyds’ regulatory writing expertise.
- [Navigating the Regulatory Landscape of Rare Disease Drug Development](https://boydconsultants.com/navigating-the-regulatory-landscape-of-rare-disease-drug-development/) - February 28, 2025, marks Rare Disease Day - a global initiative dedicated to raising awareness and driving change for the 300 million people worldwide living with a rare disease, along with their families and carers.
- [Boyds appoints Group Financial Controller](https://boydconsultants.com/boyds-appoints-group-financial-controller/) - Boyds is delighted to announce the appointment of Muhammad Nadeem who has joined the company as Group Financial Controller.
- [US growth journey: boosting the Boyds brand stateside](https://boydconsultants.com/us-growth-journey-boosting-the-boyds-brand-stateside/) - To meet growing demand for our expertise and services in the US, Boyds established a physical presence stateside in 2021, recruiting US regulatory and program management professionals to our team. As we head into 2025, we take a look back at Boyds’ US growth journey to date.
- [UK to introduce world-first regulatory framework for manufacture of innovative medicines at the point of patient care](https://boydconsultants.com/uk-to-introduce-world-first-regulatory-framework-for-manufacture-of-innovative-medicines-at-the-point-of-patient-care/) - The UK is the first country to establish a dedicated regulatory framework for manufacturing innovative medicines at or near the point of patient care
- [Director promotion for regulatory affairs professional Dr Eric Hardter](https://boydconsultants.com/director-promotion-for-regulatory-affairs-professional-dr-eric-hardter/) - Boyds is delighted to announce the promotion of Eric Hardter to Director of Regulatory Affairs.
- [EU AI Act: considerations for medical device developers](https://boydconsultants.com/eu-ai-act-considerations-for-medical-device-developers/) - In this blog, Eamonn McGowran, Associate Director of Regulatory Affairs at Boyds explains the scope of the Act and key considerations for medical device developers.
- [Why work with an Interim Chief Medical Officer?](https://boydconsultants.com/why-work-with-an-interim-chief-medical-officer/) - In this article, Dr Karen Mullen, Chief Medical Officer at Boyds, explores the benefits and value of hiring an interim Chief Medical Officer.
- [Patient advocacy: the critical role of patient engagement in clinical trials](https://boydconsultants.com/patient-advocacy-the-critical-role-of-patient-engagement-in-clinical-trials/) - In this blog, Chris Moore, Senior Clinical Project Manager, explores the role of public and patient advocacy and engagement in the clinical trial planning process.
- [Dr Katherine Bowen promoted to Vice President of Regulatory Affairs](https://boydconsultants.com/dr-katherine-bowen-promoted-to-vice-president-of-regulatory-affairs/) - Boyds has announced the appointment of Dr Katherine Bowen to Vice President of Regulatory Affairs.
- [Boyds appoints regulatory affairs professional](https://boydconsultants.com/boyds-appoints-regulatory-affairs-professional/) - Boyds is delighted to announce the appointment of Matt O’Connor who joins the company as Senior Manager, Regulatory Affairs.
- [Prof Alan Boyd awarded Fellowship of the British Pharmacological Society](https://boydconsultants.com/prof-alan-boyd-awarded-fellowship-of-the-british-pharmacological-society/) - Professor Alan Boyd, CEO and President of Boyds, has been awarded Fellowship of the British Pharmacological Society (BPS). The prestigious award recognises Alan's standout contribution to pharmacology.
- [Trio of shortlistings for Boyds in TOPRA Awards 2024](https://boydconsultants.com/trio-of-shortlistings-for-boyds-in-topra-awards-2024/) - The Boyds team has been shortlisted for three categories in the TOPRA Awards for Regulatory Excellence 2024.
- [Ada Lovelace Day 2024: empowering women in STEM](https://boydconsultants.com/ada-lovelace-day-2024-empowering-women-in-stem/) - To mark Ada Lovelace Day, we spoke to Katherine Bowen, Senior Director of Regulatory Affairs at Boyds, about the inspiration behind her STEM career, how she overcame challenges along the way, and ways to encourage more women to work in STEM.
- [Don’t fall at the last hurdle: how to select the right eCTD vendor](https://boydconsultants.com/dont-fall-at-the-last-hurdle-how-to-select-the-right-ectd-vendor/) - In the fast-paced world of drug development, navigating the regulatory landscape can feel like running a marathon with hurdles at every turn. One of the critical checkpoints in this race is the submission of electronic Common Technical Documents (eCTD) to the regulatory authorities, such as FDA, MHRA and EMA.
- [Boyds announces four promotions](https://boydconsultants.com/boyds-announces-four-promotions/) - Boyds is pleased to announce the following promotions across the company.
- [Navigating the challenges of developing delivery devices for cell and gene therapy products in Europe](https://boydconsultants.com/navigating-the-challenges-of-developing-delivery-devices-for-cell-and-gene-therapy-products-in-europe/) - An article authored by Dr Patrick Ginty, Senior Director of Regulatory Affairs at Boyds, and Eamonn McGowran, Associate Director of Regulatory Affairs, has been published in Cell & Gene Therapy Insights’ August 2024 ‘Spotlight On’ innovation in cellular immunotherapy.
- [Demystifying regulatory designations in drug development](https://boydconsultants.com/demystifying-regulatory-designations-in-drug-development/) - In this blog, regulatory experts, Dr Julie Warner and Dr Katherine Bowen explore a number of regulatory designations and the complexities they can present.
- [Medical student guest blog: my work placement at Boyds](https://boydconsultants.com/medical-student-guest-blog-my-work-placement-at-boyds/) - Boyds recently welcomed fifth year medical student Sam Mayhew to the company for work placement, where he undertook a research project.
- [How to become investor ready: a guide for early-stage biotechs](https://boydconsultants.com/how-to-become-investor-ready-a-guide-for-early-stage-biotechs/) - This blog offers a comprehensive guide for early-stage and start-up biotech companies on preparing to be investor ready and secure the necessary funding for advancing their drug development programs.
- [Dr Harriet Gray Stephens completes Pharmaceutical Medicine Specialty Training](https://boydconsultants.com/dr-harriet-gray-stephens-completes-pharmaceutical-medicine-specialty-training/) - We are delighted to congratulate Dr Harriet Gray Stephens MFPM on completing her Pharmaceutical Medicine Specialty Training (PMST).
- [Dr Harriet Gray Stephens discusses the pros and cons of synthetic control arms in clinical trials](https://boydconsultants.com/dr-harriet-gray-stephens-discusses-the-pros-and-cons-of-synthetic-control-arms-in-clinical-trials/) - An article authored by Dr Harriet Gray Stephens MFPM, medical director at Boyds, has been published on the Clinical Leader website.
- [Chris Moore shares top tips for US biotechs setting up clinical studies in Europe](https://boydconsultants.com/chris-moore-shares-top-tips-for-us-biotechs-setting-up-clinical-studies-in-europe/) - Chris Moore, Clinical Project Manager at Boyds, discusses 10 considerations for US biotechs setting up clinical studies in Europe.
- [National DNA Day: Gene Therapy - The future has arrived.](https://boydconsultants.com/national-dna-day-gene-therapy-the-future-has-arrived/) - Boyds congratulates Katy Rudnick, Head of US Regulatory Affairs, on being awarded the Aiko Maruya award for excellence in regulatory science.
- [A reflection on the EU Clinical Trials Regulation and future prospects](https://boydconsultants.com/a-reflection-on-the-eu-clinical-trials-regulation-and-future-prospects/) - The field of clinical trials within the European Union (EU) has undergone a significant transformation in recent years driven by implementation of the new Clinical Trials Regulation (EU No 536/2014) (CTR) aimed at harmonisation of the rules across the EU for conducting clinical trials, enhancing patient safety, data transparency and overall trial efficiency.
- [Clinical pharmacology student completes internship with Boyds](https://boydconsultants.com/clinical-pharmacology-student-completes-internship-with-boyds/) - Boyds recently welcomed Clinical Pharmacology BSc student Salma Muse to the team on a six-week internship.
- [Preparing for the Clinical Trials Regulation (CTR)](https://boydconsultants.com/preparing-for-the-clinical-trials-regulation-ctr/) - The CTR (Regulation (EU) No 536/2014) replaces the EU Clinical Trials Directive and local implementing legislation and provides the requirements for conducting clinical trials in member states of the European Union (EU).
- [The Clinical Trials Regulation and the Clinical Trials Information System](https://boydconsultants.com/the-clinical-trials-regulation-and-the-clinical-trials-information-system/) - The way clinical trials (CTs) are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) comes into application on 31 January 2022.
- [The Maddi Foundation selected as Boyds’ Charity of the Year](https://boydconsultants.com/the-maddi-foundation-selected-as-boyds-charity-of-the-year/) - We are proud to announce that we have chosen to support The Maddi Foundation as our Charity of the Year for 2024.
- [Harriet Edwards explores the current landscape for genome editing technologies](https://boydconsultants.com/harriet-edwards-explores-the-current-landscape-for-genome-editing-technologies/) - Harriet Edwards, Associate Director of Regulatory Affairs at Boyds, has authored an article exploring genome editing in Cell & Gene Therapy Insights.
- [The latest trends in US drug development](https://boydconsultants.com/the-latest-trends-in-us-drug-development/) - In this blog, Katy Rudnick, Vice President and Head of US Regulatory Affairs at Boyds, explores the latest trends in US drug development and initiatives at the FDA and discusses their potential impact on drug development in 2024.
- [How To De-Risk Your IND Webinar](https://boydconsultants.com/how-to-de-risk-your-ind-webinar/) - On March 20, 2024 at 9 am PST, Boyds will host a webinar designed to provide attendees with a plan of action that can help to de-risk your Investigational New Drug (IND) application and expedite the path to gain study clearance.
- [Navigating the complexities of rare disease drug development](https://boydconsultants.com/navigating-the-complexities-of-rare-disease-drug-development/) - In this article, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, discusses the investigational phase of the rare disease drug development process with a focus on US regulatory requirements.
- [Progress of cell and gene therapies](https://boydconsultants.com/progress-of-cell-and-gene-therapies/) - A blog discussing the development of cell and gene therapies over the past few years.
- [Regulation of medical and in vitro diagnostic medical devices in the UK (Great Britain and Northern Ireland)](https://boydconsultants.com/regulation-of-medical-and-in-vitro-diagnostic-medical-devices-in-the-uk-great-britain-and-northern-ireland/) - In the European Union (EU), medical and in vitro diagnostic medical devices are regulated by an EU framework that aims to ensure that all devices available for use on the EU market are safe and perform as intended
- [Scientific advice (US-FDA)](https://boydconsultants.com/scientific-advice-us-fda/) - The FDA has four meeting types, type A (help a stalled product development program), type B (pre-IND meeting, pre- NDA/BLA meeting, meeting to discuss overall development for products granted breakthrough therapy designation), end of phase type B (certain end of phase 1 meetings, end of phase 2 and pre phase 3 meetings), and type C (any meeting regarding development and review of a product that isn’t any of the other types).
- [Orphan Drug Designation (EU & UK)](https://boydconsultants.com/orphan-drug-designation-eu-uk/) - Regulatory Factsheet Orphan Drug Designation (EU & UK) In order to be eligible for Orphan Drug Designation (ODD) with the EMA, a product must fulfill certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market. Download our 2 page Orphan Drug
- [Orphan Drug Designation (US)](https://boydconsultants.com/orphan-drug-designation-us/) - The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease. Download our 2-page Orphan Drug Designation (US) factsheet for more information.
- [Boyds is now a proud member of MassBio](https://boydconsultants.com/boyds-is-now-a-proud-member-of-massbio/) - As part of our continued growth plans in the US, Boyds is delighted to join MassBio as a proud member.
- [Boyds joins Texas Healthcare and Bioscience Institute (THBI) as proud member](https://boydconsultants.com/boyds-joins-texas-healthcare-and-bioscience-institute-thbi-as-proud-member/) - Boyds is delighted to have been named as a finalist in the Business Support category of the BioNow Awards 2023.
- [The FDA Pre-IND Meeting – A Best Practice for Mitigating Early Regulatory Risk](https://boydconsultants.com/the-fda-pre-ind-meeting-a-best-practice-for-mitigating-early-regulatory-risk/) - In this blog, Dr Eric Hardter, Associate Director of Regulatory Affairs, discusses the critical importance of proper planning and early engagement with FDA for Investigational New Drug (IND) applications.
- [Boyds shortlisted for BioNow Business Support Award](https://boydconsultants.com/boyds-shortlisted-for-bionow-business-support-award/) - Boyds is delighted to have been named as a finalist in the Business Support category of the BioNow Awards 2023.
- [Navigating the regulatory landscape in oncology drug development](https://boydconsultants.com/navigating-the-regulatory-landscape-in-oncology-drug-development/) - In this blog, Boyds’ Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU.
- [Dr Harriet Gray Stephens reviews key complexities and emerging trends in early-phase oncology clinical trials for ATMPs](https://boydconsultants.com/dr-harriet-gray-stephens-reviews-key-complexities-and-emerging-trends-in-early-phase-oncology-clinical-trials-for-atmps/) - An article authored by Dr Harriet Gray Stephens MFPM, Pharmaceutical Physician in the Clinical and Medical Affairs team at Boyds, has been published in Cell & Gene Therapy Insights.
- [Medical monitors in clinical trials: the linchpin between patients and sponsors](https://boydconsultants.com/medical-monitors-in-clinical-trials-the-linchpin-between-patients-and-sponsors/) - A blog discussing the importance of expert independent medical monitors oversight early on during study set up processes.
- [Navigating the challenges faced by Medical Directors](https://boydconsultants.com/navigating-the-challenges-faced-by-medical-directors/) - Dr Karen Mullen, Chief Medical Officer at Boyds explains how getting the right support can help Medical Directors to excel in their role, navigate the challenges, and implement the practices to create a high-performing, and effective medical department.
- [Strategic study start-up support in the UK and Europe](https://boydconsultants.com/strategic-study-start-up-support-in-the-uk-and-europe/) - Boyds was engaged to provide a client in the US with study start-up support services in the UK and France for a gene therapy study in patients with an ocular condition.
- [Providing support for a phase 2 study in patients with metastatic breast cancer in the UK and EU](https://boydconsultants.com/providing-support-for-a-phase-2-study-in-patients-with-metastatic-breast-cancer-in-the-uk-and-eu/) - Boyds provided services to assist an EU Sponsor with the set up and ongoing site management of a study in patients with advanced metastatic breast cancer in the UK and Spain.
- [Chris Moore discusses key considerations for US biotechs setting up gene therapy studies in Europe](https://boydconsultants.com/chris-moore-discusses-key-considerations-for-us-biotechs-setting-up-gene-therapy-studies-in-the-uk-and-europe/) - In the viewpoint article: ‘Key considerations for US biotechs setting up gene therapy studies in the UK and Europe’, Chris highlights some of the important things organisations must consider before initiating their study.
- [The importance of diversity in clinical trials](https://boydconsultants.com/the-importance-of-diversity-in-clinical-trials/) - In this article, Dr Harriet Gray-Stephens, Pharmaceutical Physician in the Clinical and Medical Affairs team at Boyds, discusses the importance of diversity in clinical trials and the steps that are being taken to improve the quality of data derived from clinical research.
- [Rare Disease Day: Gene therapy trends and innovation for rare diseases](https://boydconsultants.com/rare-disease-day-gene-therapy-trends-and-innovation-for-rare-diseases/) - To mark Rare Disease Day 2023, Professor Alan Boyd, President and CEO of Boyds, spoke to Cell and Gene Therapy Insights.
- [Boyds Regulatory experts join AAPS as guest speakers on Webinar](https://boydconsultants.com/boyds-regulatory-experts-join-aaps-as-guest-speakers-on-webinar-highlighting-us-and-european-regulatory-requirements-for-gene-and-cell-therapy-products/) - Boyds' Regulatory experts, Dr Patrick Ginty and Dr Sabine Rühle, join AAPS as guest speakers for a Webinar “Highlighting US and European Regulatory Requirements for Gene and Cell Therapy Products”
- [Boyds’ Patrick Ginty presenting at the TOPRA Symposium](https://boydconsultants.com/boyds-patrick-ginty-presenting-at-the-topra-symposium/) - Senior Director of Regulatory Affairs Patrick Ginty will be speaking at the TOPRA Symposium, taking place in Lisbon from the 23-25 October.
- [Ada Lovelace Day 2023: turning curiosity into a career](https://boydconsultants.com/ada-lovelace-day-2023-turning-curiosity-into-a-career/) - On Ada Lovelace Day, Dr Karen Mullen discusses what inspired her to pursue a career in STEM and how to encourage more women to consider careers in the industry.
- [MHRA announces new pathway for device regulations](https://boydconsultants.com/mhra-announces-new-pathway-for-device-regulations/) - The Medicines and Healthcare products Regulatory Agency (MHRA) has published the “MHRA Roadmap towards the future regulatory framework for medical devices”. With the of release of this document on the 9th January 2024, the Agency has provided an update on the intended timelines to implement the future core regulations via a series of new Statutory Instruments.
- [Eamonn McGowran: Medical Devices Regulatory Specialist joins Boyds](https://boydconsultants.com/medical-devices-regulatory-specialist-eamonn-mcgowran-joins-boyds/) - Boyds welcomes Medical Devices Regulatory Specialist, Eamonn McGowran, marking the beginning of the next phase of growth and expansion in Dublin and Europe.
- [Boyds launches ‘Conversations in Drug Development’ podcast](https://boydconsultants.com/boyds-launches-conversations-in-drug-development-podcast/) - Boyds has announced the launch of a brand-new podcast series that aims to keep the scientific and clinical community abreast of the latest advancements in cell and gene therapy and drug development.
- [A guide to plain language summaries (PLS)](https://boydconsultants.com/a-guide-to-plain-language-summaries-pls/) - In this blog, Naomi Clout, Senior Regulatory and Medical Writer at Boyds, discusses the importance of Plain Language Summaries as an effective scientific communication tool that can be easily comprehended by people who aren't experts in the field and the steps involved in creating a PLS.
- [Boyds collaborates with BioPharma Connections](https://boydconsultants.com/boyds-collaborates-with-biopharma-connections/) - Boyds partners with BioPharma Connections in the company’s latest move to continue its growth in the U.S.
- [Dr Harriet Gray Stephens](https://boydconsultants.com/meet-the-medics-dr-harriet-gray-stephens/) - The UK has launched The Innovative Devices Access Pathway (IDAP) pilot, a new pathway to support the rapid development of innovative technologies.
- [Double win for Boyds at TOPRA Awards 2023](https://boydconsultants.com/double-win-for-boyds-at-topra-awards-2023/) - The TOPRA Awards 2023 saw Boyds' regulatory affairs team crowned winners of the Futures Award and Katherine Bowen winner of the Inspiration Award.
- [EU Pharmaceutical Legislation Reform – Impact on clinical trials for innovative GMO medicines](https://boydconsultants.com/eu-pharmaceutical-legislation-reform-impact-on-clinical-trials-for-innovative-gmo-medicines/) - To address challenges faced in Europe’s pharmaceutical sector, the European Commission (EC) has proposed a new pharmaceutical strategy for Europe¹. This patient-centred strategy aims at creating a future-proof regulatory framework to ensure that patients have access to high-quality, effective and safe medicines, while boosting the sector’s global competitiveness.
- [Boyds grows regulatory affairs team with new hire](https://boydconsultants.com/boyds-grows-regulatory-affairs-team-with-new-hire/) - Boyds has announced the appointment of Monica Pianella as Associate Director of Regulatory Affairs.
- [The UK Innovative Devices Access Pathway (IDAP) pilot scheme now open for application](https://boydconsultants.com/the-uk-innovative-devices-access-pathway-idap-pilot-scheme-now-open-for-application/) - The UK has launched The Innovative Devices Access Pathway (IDAP) pilot, a new pathway to support the rapid development of innovative technologies.
- [Experts at Boyds share ten top tips for starting an early phase clinical trial](https://boydconsultants.com/experts-at-boyds-share-ten-top-tips-for-starting-an-early-phase-clinical-trial/) - The clinical operations and medical affairs experts at Boyds have shared their ten top tips for how to start and promote the success of early phase clinical trials.
- [Paediatric Development Harmonisation in Europe and the US: Myth or Reality?](https://boydconsultants.com/paediatric-development-harmonisation-in-europe-and-the-us-myth-or-reality/) - In this blog, Celine Courtay-Cahen, Senior Manager, Regulatory Affairs, explores the challenges and prospects of harmonising paediatric drug development efforts between the European Union and the United States.
- [Professor Alan Boyd welcomes the Innovative Devices Access Pathway (IDAP) pilot](https://boydconsultants.com/professor-alan-boyd-welcomes-the-innovative-devices-access-pathway-idap-pilot/) - Professor Alan Boyd welcomes the Innovative Devices Access Pathway (IDAP) pilot for medical devices that recently launched in the UK.
- [UK rejoins EU Horizon scheme: Professor Alan Boyd comments](https://boydconsultants.com/uk-rejoins-eu-horizon-scheme-professor-alan-boyd-comments/) - The government has announced that the UK is to rejoin the EU's flagship scientific research scheme, Horizon.
- [Boyds strengthens team with regulatory operations and publishing expertise](https://boydconsultants.com/boyds-strengthens-team-with-regulatory-operations-and-publishing-expertise/) - Boyds is pleased to announce the appointment of regulatory operations and publishing professional Michelle Hackney to lead our new in-house Regulatory Operations offering.
- [Webinar: How to successfully operationalize real-world data collection alongside expanded access programs](https://boydconsultants.com/webinar-how-to-successfully-operationalize-real-world-data-collection-alongside-expanded-access-programs/) - On 05 October, Boyds will be co-hosting a live webinar with Cisiv, discussing how to successfully operationalize real-world data collection alongside expanded access programs.
- [Regulatory affairs team bolstered with appointment of Submissions Compliance and Quality Manager](https://boydconsultants.com/navila-rehman-joins-boyds-regulatory-affairs-team/) - Navila Rehman has joined Boyds in the newly created role of Submissions Compliance and Quality Manager within the regulatory affairs team.
- [Opportunities in Clinical Research](https://boydconsultants.com/opportunities-in-clinical-research/) - One Nucleus recently hosted their Building Life Science Adventures Conference which focused on career opportunities such as clinical research
- [Overcoming the Barriers to the Development of Medicines for Ultra Rare Diseases](https://boydconsultants.com/overcoming-the-barriers-to-the-development-of-medicines-for-ultra-rare-diseases/) - In the third and final article in the series on Orphan Drugs, Bryan Hurst discusses how to overcome the barriers to the development of medicines for the treatment of ultra rare diseases.
- [Karen Mullen recognised as a Global Fellow in Medicines Development](https://boydconsultants.com/karen-mullen-recognised-as-a-global-fellow-in-medicines-development/) - We are delighted to congratulate Chief Medical Officer at Boyds, Dr Karen Mullen, on being recognised as a Global Fellow in Medicines Development (GFMD)
- [Boyds expands regulatory affairs team in the US](https://boydconsultants.com/boyds-expands-regulatory-affairs-team-in-the-us/) - Boyds is delighted to announce the appointment of Eric Hardter, who will join the award-winning regulatory affairs team at Boyds, based in the US.
- [Clinical study management: the key to trial success](https://boydconsultants.com/clinical-study-management-the-key-to-trial-success/) - Boyds has a wealth of experience in clinical study management, and in this blog, Dr Karen O’Hanlon sets out the approach the team follows to help maximise trial success.
- [Professor Alan Boyd explains the science behind gene therapy in Open Access Government article](https://boydconsultants.com/professor-alan-boyd-explains-the-science-behind-gene-therapy-in-open-access-government-article/) - Prof Alan Boyd recently sat down with Open Access Government to explain the science behind gene therapy, challenges in treating genetic diseases and current trends.
- [#AgileLeaders Forum on Successful Development of C&G Therapies](https://boydconsultants.com/agileleaders-forum-on-successful-development-of-cg-therapies/) - We are excited to announce our involvement in the upcoming #AgileLeaders Forum on Successful Development of C&G Therapies, with special guest speaker, Professor Alan Boyd.
- [Boyds announced as Proud Patron of CAT FM](https://boydconsultants.com/boyds-announced-as-proud-patrons-of-cat-fm/) - The Cat, local radio station for Crewe and Nantwich, has announced a partnership with Boyds, global drug development consultancy.
- [Orphan Drug Development](https://boydconsultants.com/orphan-drug-development/) - This is the first in a series of articles aiming to highlight the vital role that orphan drug development consultants play in helping small pharma companies to bring new medicines to the market.
- [Programme management: the backbone of successful product development](https://boydconsultants.com/programme-management-the-backbone-of-successful-product-development/) - Why is professional programme management support key to biotechs in progressing their ideas into medicines for patients?
- [CTD to CTR: Clinical Trials Regulation: ongoing trials beyond 31 January 2025](https://boydconsultants.com/ctd-to-ctr-clinical-trials-regulation-ongoing-trials-beyond-31-january-2025/) - If you are running any clinical trials, approved under the Clinical Trials Directive, that will continue to run after 31 January 2025, you will need to comply with the Clinical Trials Regulation (Regulation (EU) No 536/2014)
- [Boyds announces trio of promotions](https://boydconsultants.com/boyds-announces-trio-of-promotions/) - Leading drug development consultancy Boyds has made a series of promotions across the company.
- [Dr Karen Mullen awarded Fellowship of the Royal College of Physicians](https://boydconsultants.com/dr-karen-mullen-awarded-fellowship-of-the-royal-college-of-physicians/) - Boyds’ Vice President, Clinical and Medical Affairs and Chief Medical Officer Dr Karen Mullen has been awarded Fellowship of the Royal College of Physicians.
- [Boyds Regulatory Team contribute to May issue of Regulatory Rapporteur](https://boydconsultants.com/boyds-regulatory-team-contribute-to-may-issue-of-regulatory-rapporteur/) - In May's issue of the TOPRA journal, Regulatory Rapporteur, members of Boyds' award-winning regulatory team made significant contributions to the respected, international peer-reviewed journal.
- [New senior hire for medical writing team at Boyds with appointment of Naomi Clout](https://boydconsultants.com/new-senior-hire-for-medical-writing-team-at-boyds-with-appointment-of-naomi-clout/) - We are delighted to welcome Naomi Clout to the team as Senior Regulatory and Medical Writer, after working with the company on a consultancy basis for a number of years.
- [Carving out a career as a female pharma leader: interview with Dr Karen Mullen](https://boydconsultants.com/carving-out-a-career-as-a-female-pharma-leader-interview-with-dr-karen-mullen/) - Boyds’ Chief Medical Officer Dr Karen Mullen was recently interviewed by Pf Media, "Carving out a career as a female pharma leader"
- [Considerations for US Biotechs looking to set up gene therapy studies in the UK and Europe](https://boydconsultants.com/considerations-for-us-biotechs-looking-to-set-up-gene-therapy-studies-in-the-uk-and-europe/) - In our latest blog, Chris Moore explores the key challenges faced by US biotech companies planning to initiate their gene therapy studies in the UK or Europe.
- [Boyds supports fledgling biotech company](https://boydconsultants.com/case-study-boyds-supports-fledgling-biotech-company/) - When trying to secure investment for your biotech from investors or a Venture Capital (VC) company it is essential to have a well-developed, integrated development plan.
- [Expansion of oncology clinical programme into other indications](https://boydconsultants.com/expansion-of-oncology-clinical-programme-into-other-indications/) - The client came to Boyds with an exciting cell therapy programme that released its active molecule selectively in solid tumour cells.
- [Supporting new biotech companies spinning out of academia](https://boydconsultants.com/case-studies-supporting-new-biotech-companies-spinning-out-of-academia/) - Boyds played an important role in the formation of academia spin-out, Axovia, by providing technical and strategic support, alongside product development plans for the company's drug programmes.
- [Mitigating the risks with scientific due diligence](https://boydconsultants.com/scientific-due-diligence/) - For biotech and life sciences companies, entering a partnership deal can feel like a risk-driven path. Boyds explains how scientific due diligence can mitigate those risks.
- [Boyds supports acquisition of UK-based oncology drug developer with scientific due diligence](https://boydconsultants.com/boyds-supports-acquisition-of-uk-based-oncology-drug-developer/) - Boyds supports the acquisition of UK-based oncology drug developer with detailed scientific due diligence.
- [Assessment of novel vaccine technology triggers further investment](https://boydconsultants.com/case-study-assessment-of-novel-vaccine-technology-triggers-further-investment/) - The Boyds team provided the assessment of a novel vaccine technology to trigger further investment for large multi-national fund client.
- [Experts at Boyds talk funding for cell and gene therapy development](https://boydconsultants.com/experts-at-boyds-talk-funding-for-cell-and-gene-therapy-development/) - Dr Nick Meyers and Dr Neil Fish discuss the availability of funding for cell and gene therapy product development, and how organisations can differentiate themselves in the market to attract investment.
- [Spring Budget: R&D tax relief rate announcement](https://boydconsultants.com/spring-budget-rd-tax-relief-rate-announcement/) - In the Spring Budget, the Chancellor has announced an enhanced R&D tax relief rate for ‘R&D intensive SMEs.’ Professor Alan Boyd, CEO and president of Boyds, responds to the news.
- [Dr Karen Mullen interviewed for pharmaphorum article](https://boydconsultants.com/dr-karen-mullen-interviewed-for-pharmaphorum-article/) - Dr Karen Mullen recently caught up with pharmaphorum to discuss patient centricity and the changing pharmaceutical vista
- [Further growth for regulatory affairs team at Boyds with appointment of Harriet Edwards](https://boydconsultants.com/further-growth-for-regulatory-affairs-team-at-boyds-with-appointment-of-harriet-edwards/) - We are thrilled to announce the appointment of regulatory expert, Harriet Edwards who joins Boyds as Associate Director, Regulatory Affairs.
- [Boyds bolsters US team with hire of experienced product development professional Ami Patel](https://boydconsultants.com/boyds-bolsters-us-team-with-hire-of-experienced-product-development-professional/) - Boyds has bolstered its US team with the appointment of experienced pharmaceutical product development professional Ami Patel PhD.
- [Further growth for Boyds’ clinical operations team with hire of Chris Moore](https://boydconsultants.com/further-growth-for-boyds-clinical-operations-team/) - Boyds has bolstered its Clinical Operations team with the appointment of Chris Moore as Clinical Project Manager to support the growing demand for our specialist clinical trial expertise.
- [Boyds US Office: celebrating one year](https://boydconsultants.com/boyds-us-office-celebrating-one-year/) - Boyds took the bold step to open its US office in September 2021, appointing Katy Rudnick as Vice President and Head of US Regulatory Affairs to head up the newly established office. One year on, we reflect on the last twelve months and look to the future.
- [Boyds expands regulatory affairs team with experienced senior hire of Katherine Bowen](https://boydconsultants.com/boyds-expands-regulatory-affairs-team-with-experienced-senior-hire/) - Boyds is delighted to announce the appointment of experienced regulatory professional, Katherine Bowen, who joins us as Senior Director of Regulatory Affairs.
- [Boyds regulatory affairs article published by Drug Discovery World](https://boydconsultants.com/boyds-regulatory-affairs-article-published-by-drug-discovery-world/) - An article authored by Dr Julie Warner, Vice President of Regulatory Affairs, has been featured by Drug Discovery World - the multi-platform global voice for the drug discovery community.
- [Eamonn McGowran explains developments in regulation for medical devices in Med-Tech Innovation article](https://boydconsultants.com/eamonn-mcgowran-explains-developments-in-regulation-for-medical-devices-in-med-tech-innovation-article/) - An article published in Med-Tech Innovation and authored by Eamonn McGowran, explains the developments in regulation for Medical devices.
- [What is a Target Product Profile and when is it needed?](https://boydconsultants.com/what-is-a-target-product-profile-and-when-is-it-needed/) - The team at Boyds are strong advocates of using Target Product Profiles to help clarify what needs to be achieved when developing products and to keep the teams focused on delivering a product that meets or exceeds expectations.
- [European Commission proposes extension of Medical Devices Regulation transition period in bid to prevent medical device shortages](https://boydconsultants.com/european-commission-proposes-extension-of-mdr-transition-periods-in-a-bid-to-prevent-medical-device-shortages/) - Boyds outlines and explains all the latest guidance and development surrounding the Medical Devices Regulation (EU) 2017/745 (MDR)
- [Preventing fake medicines from reaching patients](https://boydconsultants.com/preventing-fake-medicines-from-reaching-patients/) - Boyds' Director of Regulatory Affairs, Julie Warner, has co-edited an article in the October issue of the TOPRA journal, Regulatory Rapporteur, which focuses on falsified / fake medicines.
- [Supporting the development of treatments for rare diseases – it’s in our DNA](https://boydconsultants.com/supporting-the-development-of-treatments-for-rare-diseases/) - Professor Alan Boyd reflects on the work his team carries out to support the development of new medicines to treat rare diseases
- [Professor Alan Boyd awarded FPM President’s Medal](https://boydconsultants.com/professor-alan-boyd-awarded-fpm-presidents-medal/) - A huge congratulations to our CEO and Founder, Professor Alan Boyd, on being awarded the President’s Medal by the Faculty of Pharmaceutical Medicine.
- [Dr Harriet Gray Stephens awarded membership to the Faculty of Pharmaceutical Medicine (MFPM)](https://boydconsultants.com/dr-harriet-gray-stephens-becomes-a-member-of-the-faculty-of-pharmaceutical-medicine-mfpm/) - A huge congratulations to Dr Harriet Gray Stephens on being awarded membership of the Faculty of Pharmaceutical Medicine.
- [US Agent Services](https://boydconsultants.com/us-agent-services-boyds/) - This article discusses the resposibilities of US Agent Services acting as a primary contact to liaise with the FDA.
- [Boyds US Virtual Roadshow - Pennsylvania](https://boydconsultants.com/boyds-virtual-roadshow/) - We know how difficult it is to develop new medicines and navigate the regulatory pathway to ensure treatments are approved and made available to patients. Meet the team on our virtual roadshow!
- [Boyds US office provides launchpad for US expansion](https://boydconsultants.com/boyds-us-office-provides-launchpad-for-us-expansion/) - Boyds US has opened an office in King of Prussia on the outskirts of Philadelphia.
- [Government publishes consultation report on the future regulation of medical devices in the United Kingdom](https://boydconsultants.com/government-publishes-consultation-report-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/) - Government publishes consultation report on the future regulation of medical devices in the United Kingdom. Following on from Brexit and the departure from the EU, the UK is building its own regulatory regime.
- [Reflecting on my first six months at Boyds – a blog by Dr Neil Fish](https://boydconsultants.com/reflecting-on-my-first-six-months-at-boyds-a-blog-by-dr-neil-fish/) - A blog discussing the development of cell and gene therapies over the past few years.
- [Clinical Pharmacology students join Boyds Regulatory Affairs and Clinical Operations team on placement](https://boydconsultants.com/clinical-pharmacology-students-join-boyds-regulatory-affairs-and-clinical-operations-team-on-placement/) - We welcomed students Aya Sadouki and Alicja Skorupinska to Boyds to complete their six-week placement, supporting the Regulatory Affairs and Clinical Operations teams.
- [Boyds now part of 2022 Transatlantic Growth (TAG) Tracker by BritishAmerican Business](https://boydconsultants.com/boyds-now-part-of-2022-transatlantic-growth-tag-tracker/) - We are delighted to announce Boyds is now part of the 2022 Transatlantic Growth (TAG) Tracker by BritishAmerican Business
- [Dr Karen Mullen appointed as Chief Medical Officer](https://boydconsultants.com/dr-karen-mullen-appointed-as-chief-medical-officer/) - Boyds is delighted to announce the appointment of experienced pharmaceutical physician Dr Karen Mullen FFPM as Chief Medical Offer (CMO) and Vice President of Clinical and Medical Affairs.
- [Boyds bolsters clinical operations team as demand for clinical trial expertise and support surges](https://boydconsultants.com/boyds-bolsters-clinical-operations-team-as-demand-for-clinical-trial-expertise-and-support-surges/) - Leading global drug development consultancy Boyds has appointed experienced clinical researcher Caroline Corbett as Director of Clinical Operations to support the team’s continued growth and the rising demand for its specialist clinical trial expertise.
- [Boyds adds medical writer, Vicky Wheeldon, to growing Regulatory Affairs team](https://boydconsultants.com/boyds-adds-medical-writer-vicky-wheeldon-to-growing-regulatory-affairs-team/) - Leading global drug development consultancy Boyds has appointed experienced medical writer, Vicky Wheeldon as Associate medical writer in response to sustained demand for our dedicated regulatory services.
- [Julie Warner: A regulatory roadmap to translation of ATMPs](https://boydconsultants.com/julie-warner-regulatory-landscape-for-advanced-therapies/) - Dr Julie Warner will be taking part in Regulatory Landscape for Advanced Therapies hosted by Medcity and the South West Advanced Therapies Network on the 11th May 2022.
- [UK continues to lead in Advanced Therapies](https://boydconsultants.com/uk-continues-to-lead-in-advanced-therapies/) - A blog discussing the latest data on Advanced Therapy clinical trials, released by the Cell and Gene Therapy Catapult.
- [Strong growth in the US boosts revenue for Boyds](https://boydconsultants.com/strong-growth-in-the-us-boosts-revenue-for-boyds/) - Boyds is delighted to report another strong year of growth, with an increase in excess of 20 percent year-on-year in annual revenue in the wake of increased demand for our specialist expertise across the UK, US, and Europe.
- [Boyds to chair and present at TOPRA Symposium](https://boydconsultants.com/boyds-to-chair-and-present-at-topra-symposium/) - Kathryn Parsley and Jayne Hunt of Boyds have been invited to support the SME day at this year's TOPRA Symposium in Stockholm
- [American Society of Gene and Cell Therapy Annual Meeting, Washington](https://boydconsultants.com/american-society-of-gene-and-cell-therapy-in-washington/) - Professor Alan Boyd will be chairing the Audentes Symposium session at the American Society of Gene and Cell Therapy (ASGCT) annual meeting in Washington on the 1st May 2019.
- [Julie Warner awarded TOPRA Distinguished Service Award](https://boydconsultants.com/julie-warner-awarded-topra-distinguished-service-award/) - Julie Warner, Director of Regulatory Affairs at Boyds, has been awarded the TOPRA Distinguished Service Award.This award recognises volunteers whose contributions have made a real difference to TOPRA and the profession.
- [Boyds Regulatory Team Crowned Winner at 2019 TOPRA Awards](https://boydconsultants.com/boyds-shortlisted-in-2019-topra-awards/) - Boyds Regulatory Team Crowned Winner at 2019 TOPRA Awards, taking home the trophy for the Futures category
- [Sabine Ruehle presents at BIA UK Bioscience Forum 2019 – slides now available](https://boydconsultants.com/sabine-ruehle-to-present-at-the-bia-uk-bioscience-forum-2019/) - Sabine Ruehle, Regulatory Affairs Senior Associate at Boyds, presented at the BIA UK Bioscience Forum 2019 in October at County Hall in Westminster.
- [Boyds shortlisted as finalist in South Cheshire Chamber Business Awards 2019](https://boydconsultants.com/boyds-shortlisted-as-finalist-in-south-cheshire-chamber-business-awards-2019/) - Boyds joins the list of finalists for this year's South Cheshire Chamber of Commerce Business Awards. Winners will be announced on the 22 November.
- [Chariots of Fire](https://boydconsultants.com/chariots-of-fire/) - Members of the Boyds team in Cambridge and friends, completed the Chariots of Fire run in Cambridge last month.
- [Boyds strengthens expertise with key appointment of Susan Tansey](https://boydconsultants.com/boyds-strengthens-expertise-with-key-appointment/) - Boyds is delighted to welcome Susan Tansey who joins the business as Consultant Pharmaceutical Physician.
- [Boyds acquires Blue Duck Consultancy Ltd](https://boydconsultants.com/boyds-acquires-blue-duck-consultancy-ltd/) - Boyds has enhanced its clinical and medical affairs services offering following the acquisition of Blue Duck Consultancy.
- [Boyds reports record-breaking growth 12 months on from Queen’s Award](https://boydconsultants.com/boyds-reports-record-breaking-growth-12-months-on-from-queens-award/) - Boyds has reported record-breaking growth in its overseas turnover since it was recognised with The Queen’s Awards for Enterprise last year.
- [Boyds bolsters Regulatory Affairs team with appointment of Claire Scruton](https://boydconsultants.com/boyds-bolsters-regulatory-affairs-team-with-appointment-of-claire-scruton/) - Boyds has announced a key appointment in support of its continuing growth plans, welcoming Claire Scruton as Senior Manager of CMC Regulatory Affairs.
- [Boyds strengthens Regulatory team with appointment of Sabine Rühle](https://boydconsultants.com/boyds-strengthens-regulatory-team-with-appointment-of-sabine-ruhle/) - Boyds has announced a key appointment in support of its continued growth plans, welcoming Dr Sabine Rühle as Senior Associate of Regulatory Affairs. 
- [New Dublin office in Ireland for Boyds](https://boydconsultants.com/new-dublin-office-in-ireland-for-boyds/) - Boyds has opened an office in Dublin, Ireland in a step that will ensure the continuity of service to its clients once the UK leaves the EU.
- [Professor Alan Boyd appointed as Non-Executive Director at Clinigen Group](https://boydconsultants.com/professor-alan-boyd-appointed-non-executive-director-at-clinigen-group/) - Clinigen Group plc, the global pharmaceutical and services company, has announced the appointment of Professor Alan Boyd as a Non-Executive Director.
- [Boyds presented with Queen’s Award for Enterprise](https://boydconsultants.com/queens-award-for-enterprise-presented-to-boyds/) - Boyds has been presented with The Queen’s Award for Enterprise, International Trade for Outstanding Short-Term Growth in overseas sales for the last three years.
- [Boyds shortlisted as an OBN Award finalist](https://boydconsultants.com/boyds-shortlisted-as-an-obn-award-finalist/) - Boyds has been shortlisted as a finalist in the Best Sector Support Organisation category at the 2018 OBN Awards.
- [Boyds appoints Consultant Pharmaceutical Physician](https://boydconsultants.com/boyds-appoints-consultant-pharmaceutical-physician/) - Boyds is delighted to welcome Christine Smith as a Consultant Pharmaceutical Physician to support the clinical activities of the company and in particular supporting the work being undertaken in cell and gene therapy development.
- [Boyds recognised with prestigious Queen’s Award for Enterprise](https://boydconsultants.com/boyds-recognised-with-prestigious-queens-award-for-enterprise/) - Boyds has today been recognised with one of the UK’s most prestigious business awards – The Queen’s Award for Enterprise, International Trade for Outstanding Short Term Growth in overseas sales for the last three years.
- [Clarification on the assessment of ATMPs](https://boydconsultants.com/clarification-on-the-assessment-of-atmps/) - Boyds has welcomed the very timely final Regulation (EU) 2018/781 from the European Commission which describes the criteria to be used in the assessment of similarity for orphan designated ATMPs.
- [Health & Social Care Select Committee’s report on medicines, devices and substances of human origin has now been published](https://boydconsultants.com/health-social-care-select-committees-report-medicines-devices-substances-human-origin-now-published/) - The report urges Government to seek to secure the closest possible regulatory alignment with the EU for medicines and devices in Brexit negotiations.
- [AMO Pharma announces results of Phase 2 proof-of-concept study of AMO-02 in Congenital and Childhood Onset Myotonic Dystrophy Type 1](https://boydconsultants.com/amo-pharma-announces-results-phase-2-proof-concept-study-amo-02-congenital-childhood-onset-myotonic-dystrophy-type-1/) - AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare, debilitating childhood onset neurogenetic disorders with limited or no treatment options, has announced the presentation of final data from the company's phase 2 proof-of-concept study of AMO-02, an investigational therapy for treatment of congenital and childhood onset myotonic dystrophy type 1
- [Evaluation of advanced therapy medicines](https://boydconsultants.com/evaluation-advanced-therapy-medicines/) - The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs).
- [Boyds acquires new Cambridge office to support rapid growth](https://boydconsultants.com/boyds-acquires-new-cambridge-office-support-rapid-growth/) - Drug development consultancy acquires Cambridge office to support rapid growth as it continues to work with pharmaceutical companies to translate great science into marketable medicines for patient benefit
- [European Medicines Agency to move to Amsterdam](https://boydconsultants.com/european-medicines-agency-to-move-to-amsterdam/) - Today’s ballot in Brussels, which involved representatives of every EU country (excluding the UK), has resulted in Amsterdam being selected as the new home for the European Medicines Agency (EMA).
- [Regulatory Rapporteur](https://boydconsultants.com/regulatory-rapporteur/) - Dr Julie Warner, Director of Regulatory Affairs at Boyds, is also the Associate Editor of TOPRA’s Regulatory Rapporteur journal.
- [World Cancer Day: The future of cancer treatment and the health equity gap](https://boydconsultants.com/world-cancer-day/) - Dr Neil Fish shares his thoughts about the trends in new and cutting-edge cancer treatments, as well as the challenges facing the development of oncology drugs to mark World Cancer Day.
- [Supporting the creation of new biotech companies from academia](https://boydconsultants.com/supporting-the-creation-of-new-biotech-companies-from-academia/) - With the launch of Axovia Therapeutics, a gene therapy biotech company, Nick Meyers reflects on Boyd’s involvement in the company's formation.
- [A brave new world for medical technologies](https://boydconsultants.com/a-brave-new-world-for-medical-technologies/) - Julie Warner, has co-edited an article in the October issue of the TOPRA journal, Regulatory Rapporteur, which focuses on medical technologies.
- [Advanced therapies in the UK](https://boydconsultants.com/advanced-therapies-in-the-uk/) - This blog explores the changing landscape, significant growth and clinical progress being made in the field of advanced therapies in the UK.
- [Siobhan Gaynor: From Drug Developer to Patient](https://boydconsultants.com/from-drug-developer-to-patient/) - Siobhan Gaynor: From drug developer to cancer patient following her diagnosis of metastatic breast cancer.
- [Boyds boosts specialist clinical expertise with appointment of Dr Harriet Gray Stephens](https://boydconsultants.com/boyds-boosts-specialist-clinical-expertise-with-new-hire/) - Boyds delighted to announce the appointment of Pharmaceutical Physician, Dr Harriet Gray Stephens to the Clinical and Medical Affairs.
- [Katy Rudnick awarded Aiko Maruya award for Excellence in Regulatory Science](https://boydconsultants.com/katy-rudnick-awarded-aiko-maruya-award-for-excellence-in-regulatory-science/) - Boyds congratulates Katy Rudnick, Head of US Regulatory Affairs, on being awarded the Aiko Maruya award for excellence in regulatory science.
- [Pippa Bjaaland graduates with MSc in Cancer and Clinical Oncology with distinction.](https://boydconsultants.com/pippa-bjaaland-graduates-with-msc-in-cancer-and-clinical-oncology/) - Boyds is delighted to congratulate Pippa Bjaaland, on graduating with an MSc in Cancer and Clinical Oncology from Queen Mary University of London.
- [FDA approval brings first gene therapy to the United States](https://boydconsultants.com/fda-approval-brings-first-gene-therapy-to-the-united-states/) - Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor.
- [Barriers to orphan drug development](https://boydconsultants.com/barriers-to-orphan-drug-development/) - Understanding the barriers currently restricting the development of new medicines for very rare disease (Orphan drug development)
- [EMA issues guidance document in preparation for Brexit](https://boydconsultants.com/ema-issues-adopted-guideline-on-first-in-human-trials/) - The EMA and the European Commission have published guidance to help pharma companies prepare for the UK’s withdrawal from the European Union.
- [New route to treating Alzheimer’s Dementia](https://boydconsultants.com/new-route-to-treating-alzheimers-dementia/) - Boyds has been working with Australian-based biotech company, Actinogen Medical, to develop a novel approach to the treatment of Alzheimer’s Dementia.
- [Falsified medicines – Anything but “fake news”](https://boydconsultants.com/falsified-medicines-anything-but-fake-news/) - In April, Dr Julie Warner gave an overview of the current state of play relating to the Falsified Medicines Directive in Europe.
- [Brexit’s impact on the European Medicines Agency and notice to Marketing Authorisation Holders](https://boydconsultants.com/brexits-impact-on-the-european-medicines-agency-and-notice-to-marketing-authorisation-holders/) - As no member state has left the EU before, there is no precedent for the situation the European Medicines Agency finds itself in.
- [Alan Boyd shares his passion for pharmaceutical medicine in BMJ Confidential](https://boydconsultants.com/alan-boyd-shares-his-passion-for-pharmaceutical-medicine-in-bmj-confidential/) - Alan Boyd features in this week’s BMJ Confidential, sharing his passion for pharmaceutical medicine, love of chocolate and what makes him happy.
- [Xanamem™ identified as a good candidate to investigate for the treatment of Alzheimer’s disease – Phase I data published in the British Journal of Pharmacology](https://boydconsultants.com/xanamem-identified-as-a-good-candidate-to-investigate-for-the-treatment-of-alzheimers-disease-phase-i-data-published-in-the-british-journal-of-pharmacology/) - The research paper, which was co-authored by Alan Boyd, reports that Phase I results show Xanamem™ is safe and well tolerated with no major safety issues. 
- [Virtual drug development](https://boydconsultants.com/virtual-drug-development/) - Nick Meyers, VP of Product Development at Boyds, spoke at a recent MarketsAndMarkets event on pragmatic drug development solutions for virtual and semi-virtual sponsors.
- [Victoria Marsh joins the team as Director of Regulatory Affairs](https://boydconsultants.com/victoria-marsh-joins-the-team-as-director-of-regulatory-affairs/) - Responding to sustained growth in demand for our Regulatory Services, Boyds has appointed Dr Victoria Marsh as Director of Regulatory Affairs in our Regulatory Affairs team.
- [Supporting the development and regulatory activities for the AstraZeneca-Oxford COVID-19 vaccine](https://boydconsultants.com/supporting-the-astrazeneca-oxford-covid-19-vaccine/) - With the COVID-19 vaccine now in wide use across the UK, Professor Alan Boyd reflects on the team’s involvement in this vital and ground-breaking project.
- [Professor Alan Boyd tells his story on The Cat 107.9FM](https://boydconsultants.com/professor-alan-boyd-tells-his-story-on-the-cat-107-9fm/) - Alan Boyd tells his story on The Cat 107.9FM, from his early career, to the development of cell and gene therapies, to the successful growth of Boyds.
- [Professor Alan Boyd awarded the Fellowship of the Academy of Medical Sciences](https://boydconsultants.com/professor-alan-boyd-awarded-the-fellowship-of-the-academy-of-medical-sciences/) - Boyds’ Founder and President, Professor Alan Boyd has been awarded the Fellowship of the Academy of Medical Sciences.
- [Nanomedicine comes of age](https://boydconsultants.com/nanomedicine-comes-of-age/) - Nanoparticles offer a promising way to deliver new drugs and an opportunity to revamp old treatments by improving their safety and efficacy known as nanomedicine.
- [Medical monitor support and advice for FLU-v phase IIb study for influenza](https://boydconsultants.com/medical-monitor-support-for-flu-v-phase-iib-study/) - Boyds has provided the medical monitor support and advice for the FLU-v Phase IIb clinical study to develop a vaccine against influenza
- [IBD & Tea: building trust in new treatments](https://boydconsultants.com/ibd-tea-building-trust-in-new-treatments/) - Alan Boyd took part in the New Deal debate on IBD, building trust in new treatments and understanding clinical trials.
- [Horizon 2020 New Deal project for treatment of inflammatory bowel diseases](https://boydconsultants.com/horizon-2020-new-deal-project-for-treatment-of-inflammatory-bowel-diseases/) - Boyds has been working with New Deal and a team of European partners on a nanotherapy research project into the treatment of inflammatory bowel diseases.
- [Experienced regulatory professionals join the Boyds team](https://boydconsultants.com/experienced-regulatory-professionals-join-the-boyds-team/) - Boyds is delighted to announce we have added to our regulatory team with the appointments of Shalini Gupta and Sarah Stevenson.
- [Evolution of Ethical Principles in the Practice of Pharmaceutical Medicine From a UK Perspective](https://boydconsultants.com/evolution-of-ethical-principles-in-the-practice-of-pharmaceutical-medicine-from-a-uk-perspective/) - Professor Alan Boyd has co-authored an article that looks at ethical principles in the practice of pharmaceutical medicine.
- [Dr Kim Champion joins the team as Regulatory Affairs Manager](https://boydconsultants.com/dr-kim-champion-joins-the-team-as-regulatory-affairs-manager/) - Boyds is delighted to welcome Dr Kim Champion to the Boyds team as Regulatory Affairs Manager.
- [Dr Bryan Murray joins Clinical and Medical Affairs Team](https://boydconsultants.com/dr-bryan-murray-joins-clinical-and-medical-affairs-team/) - Dr Bryan Murray has joined Boyds as a Pharmaceutical Physician within the growing Clinical and Medical Affairs team.
- [Boyds supports COVID-19 human infection study](https://boydconsultants.com/boyds-supports-covid-19-human-infection-study/) - Boyds is working in collaboration with Wellcome on a COVID-19 human infection study which aims to investigate immunity from previous COVID-19 infections
- [Boyds shortlisted in 2021 TOPRA Awards](https://boydconsultants.com/boyds-shortlisted-in-2021-topra-awards/) - Two of Boyds' regulatory team members were shortlisted in the 2021 TOPRA Awards for Regulatory Excellence.
- [Boyds opens US office](https://boydconsultants.com/boyds-opens-us-office/) - Boyds has opened its US office in Pennsylvania, and welcomes Katy Rudnick as Vice President and Head of US Regulatory Affairs.
- [Boyds Ireland relocates to Talent Garden Dublin](https://boydconsultants.com/boyds-relocates-irish-office-to-talent-garden/) - Boyds Ireland has relocated to Dublin's Talent Garden, a workplace community for innovators and entrepreneurs.
- [Boyds goes for growth with key appointment of Dr Neil Fish](https://boydconsultants.com/boyds-goes-for-growth-with-appointment-of-neil-fish/) - Boyds welcomes key hire, Dr Neil Fish as VP Business Development to support the company with its global expansion.
- [Boyds expands product development team](https://boydconsultants.com/boyds-expands-product-development-team/) - Boyds has added two experienced product development experts to its team, amid growing demand for specialist Product Development services.
- [Boyds builds on growth plans with clinical operations hire](https://boydconsultants.com/boyds-builds-on-growth-plans-with-clinical-operations-hire/) - Boyds has further strengthened its clinical operations offering with the appointment of Pippa Bjaaland as a Senior Clinical Research Associate.
- [Boyds assists researchers and developers on COVID-19 projects](https://boydconsultants.com/boyds-offers-to-support-covid-19-projects/) - With a wealth of experience in early development and translational medicine, Boyds is offering to assist researchers and developers on Covid-19 projects.
- [Alan Boyd joins Taysha Gene Therapies’ independent scientific advisory board](https://boydconsultants.com/alan-boyd-joins-taysha-scientific-advisory-board/) - Professor Alan Boyd has joined Taysha Gene Therapies' newly formed independent scientific advisory board to advance the company’s clinical development and commercialisation efforts.

## Pages

- [Home](https://boydconsultants.com/) - Expert regulatory affairs and drug development consulting for biotech and pharma. Strategy, clinical, medical and regulatory support from concept to approval.
- [Meet the Medics](https://boydconsultants.com/services/clinical-and-medical-affairs/meet-the-medics/) - In this new interview series, we sit down and meet the medics at Boyds to find out about their career backgrounds, their interest and passion for medicine, their greatest achievement – whether personal or professional - and get their insights on the latest industry trends.
- [Interim Chief Medical Officer Support](https://boydconsultants.com/services/clinical-and-medical-affairs/interim-chief-medical-officer-support/) - Boyds’ team of experienced Pharmaceutical Physicians provides flexible interim Chief Medical Officer support to biotechs
- [Medical Monitoring Services](https://boydconsultants.com/services/clinical-and-medical-affairs/medical-monitoring-services/) - Boyds has a team of experienced pharmaceutical physicians who are able to offer medical monitoring services to clients across a wide range of studies types and therapeutic modalities.
- [GA - CDO Services - Thank you](https://boydconsultants.com/cdo-services-thank-you/) - Thank you Thank you for your enquiry. A member of our team will be in touch shortly.In the meantime you can find out more about us here.
- [Contact us](https://boydconsultants.com/contact/) - Boyds has offices in Crewe, Cambridge, Dublin and Pennsylvania providing support to drug and device development in the US, UK and EU. Contact us.
- [Meet the Medics: Laurence Skillern](https://boydconsultants.com/meet-the-medics-laurence-skillern/) - Laurence Skillern is Chief Medical Officer in the Clinical and Medical Affairs team at Boyds.
- [GA - Strategic regulatory support US - July 2026](https://boydconsultants.com/strategic-regulatory-support/) - Global Regulatory Affairs Consulting for Drug Development Strategic regulatory support for biotech and pharmaceutical companies at every stage of drug development. Talk to a regulatory expert > Why Boyds? 0 + 0 + 0 0 % Years supporting global drug development Clients supported across the globe Cell & gene therapies approved with Boyds’ support Client
- [CMC Regulatory Affairs](https://boydconsultants.com/cmc-regulatory-affairs/) - Expert CMC regulatory affairs support from Boyds. We ensure your Chemistry, Manufacturing and Controls (CMC) documentation meets FDA, EMA, and MHRA standards.
- [Podcast | Conversations in Drug Development](https://boydconsultants.com/latest/podcast-conversations-in-drug-development/) - Welcome to Conversations in Drug Development, brought to you by the team at Boyds. This podcast is for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development.
- [GA - Strategic regulatory support US - New version April 2026](https://boydconsultants.com/us-fda-regulatory-consulting-ga/) - FDA regulatory consulting for biotech and pharmaceutical companies Supporting biotech, pharmaceutical and advanced therapy developers preparing IND, NDA, BLA and post-approval submissions to the FDA.Whether you’re a growing biotech without an in-house regulatory team or an established pharmaceutical company needing additional submission capacity, Boyds provides strategic and hands-on regulatory support. FDA regulatory strategy IND, NDA
- [Professor Alan Boyd](https://boydconsultants.com/professor-alan-boyd/) - Professor Alan Boyd is the founder and CEO at Boyds. A consultant pharmaceutical physician, Alan supports the development of cutting-edge treatments
- [Our Team](https://boydconsultants.com/our-team/) - Our team at Boyds is led by a senior team of professionals across regulatory, programme management, clinical operations and medical affairs.
- [Laurence Skillern](https://boydconsultants.com/laurence-skillern/) - Laurence Skillern is Chief Medical Officer at Boyds, bringing extensive experience in pharmaceutical medicine and clinical development across a broad range of therapeutic areas.
- [LI - Integrated Drug Development Expertise](https://boydconsultants.com/li-integrated-drug-development-expertise/) - Boyds is a global drug development consultancy supporting biotechs, academia, and life sciences from early strategy to regulatory approval. Speak with our experts.
- [Regulatory Affairs Consulting](https://boydconsultants.com/services/regulatory-affairs/) - Expert regulatory affairs consulting supporting FDA, EMA, and MHRA submissions. Trusted partners for IND, MAA, and BLA applications.
- [GA - Medical device service UK EU](https://boydconsultants.com/medical-device-regulatory-consulting-ga/) - Medical Device Regulatory Consulting Experts Expert support for EU MDR, IVDR, FDA requirements and global medical device approvals Bring your medical device to market with confidence.Boyds provides specialist medical device regulatory consulting across the entire product lifecycle – from early development, design and regulatory strategy through to submissions, clinical investigations, and post-market obligations. Discuss your
- [GA - Strategic regulatory support UK - New version April 2026](https://boydconsultants.com/uk-eu-regulatory-affairs-consulting-ga/) - Expert regulatory affairs consulting for pharma & biotech companies Boyds provides expert regulatory affairs consulting for pharmaceutical, biotech and advanced therapy companies seeking strategic, technical and submission-ready support across the UK and Europe.From early regulatory strategy through to CTA and MAA submissions, dossier preparation, lifecycle management and post-approval changes, we help teams reduce regulatory risk,
- [Regulatory Operations and Publishing](https://boydconsultants.com/services/regulatory-operations-and-publishing/) - Boyds provides end-to-end regulatory operations, eCTD publishing and global submissions support to ensure accurate, compliant and efficient pathways to approval.
- [Boyds' ESG Commitments](https://boydconsultants.com/boyds-esg-commitments/) - Boyds' ESG Commitments | The very nature of the work carried out by Boyds is focused on supporting the global development of medicines for patient benefit.
- [Why Boyds](https://boydconsultants.com/why-boyds/) - Discovering and developing new medicines is complex and takes time, which is why Boyds are available to help you to navigate the development pathway.
- [Early Access Programs and Real-World Data Collection](https://boydconsultants.com/services/early-access-programs-and-real-world-data-collection/) - Boyds work across the globe to provide strategic advice and guidance to enable the delivery of Early Access Programs and Real-World Data collection.
- [Pharmaceutical Due Diligence](https://boydconsultants.com/services/pharmaceutical-due-diligence/) - Boyds has the experience and expertise to provide informed pharmaceutical due diligence to clients. We understand high-quality decision-making needs to be led by an accurate assessment of the available scientific data.
- [Fractional & Interim Chief Development Officer Services](https://boydconsultants.com/services/product-development/fractional-interim-chief-development-officer-services/) - Strategic Chief Development Officer support for biotech and pharma companies, including clinical development, regulatory strategy, CMC oversight, and investor readiness.
- [Investor Readiness](https://boydconsultants.com/services/product-development/investor-readiness/) - Prepare your healthcare or biotech asset for investment with Boyds’ expert investor readiness support. We help you refine your development strategy, strengthen your data package, and clearly communicate value to secure funding and accelerate progress.
- [Pharma Product Development](https://boydconsultants.com/services/product-development/) - Boyds' experienced product development team supports clients in programme and project management throughout the drug development lifecycle
- [Clinical Study Start-Up Support](https://boydconsultants.com/services/clinical-operations/study-start-up-services/) - The clinical operations team at Boyds offers a comprehensive study start-up service to clients setting up clinical studies and trials
- [Clinical Site Monitoring](https://boydconsultants.com/services/clinical-operations/site-monitoring/) - Boyds offers clinical site monitoring for clinical studies to ensure regulatory compliance.
- [Clinical Project Management](https://boydconsultants.com/services/clinical-operations/clinical-project-management/) - From study start-up and feasibility to study close-out, the clinical operations team offers comprehensive clinical project management services.
- [Biostatistics Services](https://boydconsultants.com/services/clinical-operations/biostatistics/) - Biostatistics services from Boyds' network of trusted, UK-based biostatisticians, to advise and work with clients on study design and endpoint selection.
- [Clinical Operations Services](https://boydconsultants.com/services/clinical-operations/) - Boyds' clinical operations team offers comprehensive clinical trial monitoring and site management services from feasibility to site closeout.
- [Support for Medical Directors and CMOs](https://boydconsultants.com/services/clinical-and-medical-affairs/medical-director-cmo-support/) - The team at Boyds is on-hand to help Medical Directors and Chief Medical Officers develop the crucial skills, competencies, attitudes and behaviours needed to run a successful medical department.
- [Scientific and Medical Advice](https://boydconsultants.com/services/clinical-and-medical-affairs/scientific-and-medical-advice/) - The team at Boyds provides scientific and medical advice to clients so that they can progress a product or project through the development process.
- [Clinical and Medical Affairs](https://boydconsultants.com/services/clinical-and-medical-affairs/) - Boyds’ clinical and medical affairs team offers clients the bridge between industry and the wider medical community, supporting clients in all aspects of drug development and regulation.
- [Supporting your regulatory activities via Boyds’ SME status](https://boydconsultants.com/services/regulatory-affairs/supporting-your-regulatory-activities-via-boyds-sme-status/) - Boyds holds official EMA SME status, helping clients access EMA fee reductions, scientific advice, and regulatory support across Europe.
- [Regulatory Support for Medical Devices](https://boydconsultants.com/services/regulatory-affairs/medical-device-consulting-services/) - Expert regulatory affairs support for medical devices. Boyds guides MDR, IVDR, CE, and UKCA submissions for devices and combination products.
- [EU & UK Regulatory Submissions | EMA & MHRA Filing Support](https://boydconsultants.com/companies-looking-to-file-in-the-uk-and-europe/) - Regulatory support to help you navigate MHRA and EMA requirements, ensuring your submissions are well-prepared, compliant, and strategically aligned for approval.
- [Filing in the US | FDA Regulatory Consulting & US Agent Support | Boyds](https://boydconsultants.com/companies-looking-to-file-in-the-us/) - Get expert FDA submission support with Boyds. Our US-based team guides IND, NDA & BLA filings and acts as your trusted US Agent.
- [GA - Regulatory Operations and Publishing - Post Marketing Focus - New version April 2026](https://boydconsultants.com/regulatory-submission-services-ga/) - Expert regulatory operations support for the full post-marketing lifecycle - so you can focus on what's next. Achieving marketing authorization is a milestone, not a finish line. For companies managing a portfolio of approved products, the ongoing demands of post-marketing maintenance, regulatory submissions, eCTD publishing and lifecycle management can place significant strain on internal teams.
- [About Boyds](https://boydconsultants.com/about-boyds/) - Boyds is a global drug development consultancy helping to translate scientific research into medicinal products and treatments for the benefit of patients.
- [Privacy Policy](https://boydconsultants.com/privacy-policy/) - Boyds takes the protection of personal data very seriously. This privacy policy sets out how we process and protect user data
- [My Development TEAM](https://boydconsultants.com/services/product-development/my-development-team/) - A bespoke service available to startups and early-stage biotech companies looking to bring in the right development support in a cost-effective and flexible way
- [Regulatory and Medical Writing](https://boydconsultants.com/services/regulatory-affairs/regulatory-and-medical-writing/) - Boyds provides regulatory and medical writing services via our team of highly experienced scientific and medical writers.
- [GA - Strategic regulatory support UK - New version June 2026](https://boydconsultants.com/ga-strategic-regulatory-support-uk-new-version-june-2026/) - FDA, EMA & MHRA Regulatory affairs consulting Strategic regulatory support for pharmaceutical, biotech & advanced therapy companies Strategic and operational support for Clinical Trial Applications (CTAs), helping pharmaceutical, biotech and advanced therapy companies prepare high-quality submissions and progress clinical development with confidence.Whether you need support developing your regulatory strategy, preparing CTA documentation, coordinating dossier content
- [GA - CMC Regulatory - May 2026](https://boydconsultants.com/cmc-regulatory-support-ga/) - CMC Regulatory Affairs support for IND, CTA & IMPD submissions Boyds helps biotech and pharmaceutical companies develop submission-ready Chemistry, Manufacturing and Controls (CMC) strategies that meet FDA, EMA and MHRA expectations.From Module 3 authoring and IMPD preparation through to lifecycle management and agency interactions, our CMC specialists help reduce regulatory risk, avoid costly delays, and
- [Meet the Medics: Alan Boyd](https://boydconsultants.com/meet-the-medics-alan-boyd/) - Meet the Medics Physicians Experts Professor Alan Boyd is the President and CEO of Boyds. He founded the company in 2005 to support the translation of ideas into medicinal products and treatments for patient benefit. He has since grown the company globally with offices in the UK, Ireland, and the US. Here, we discover more
- [Meet the Medics: Bryan Murray](https://boydconsultants.com/meet-the-medics-bryan-murray/) - Meet the Medics Physicians Experts Dr Bryan Murray MBBS is a Pharmaceutical Physician in our Clinical and Medical Affairs team. Bryan had been working with Boyds as a consultant for over five years before joining the growing Clinical and Medical Affairs team permanently in January 2021. He is an experienced trials physician with over 13
- [Meet the Medics: Kate Owen](https://boydconsultants.com/meet-the-medics-kate-owen/) - Kate Owen is Medical Director in the Clinical and Medical Affairs team at Boyds.
- [Meet the Medics: Harriet Gray Stephens](https://boydconsultants.com/meet-the-medics-harriet-gray-stephens/) - Meet the Medics Physicians Experts Dr Harriet Gray-Stephens MFPM is a Pharmaceutical Physician at Boyds. Working in the Clinical and Medical Affairs team, Harriet provides strategic support to clients on the medical aspects of pharmaceutical development, including regulatory and clinical development activities. With over five years of experience in the industry, she is well versed
- [GA - CMC Regulatory - May 2026 - Thank you](https://boydconsultants.com/cmc-regulatory-ga-thank-you/) - Thank you Thank you for your enquiry. A member of our team will be in touch shortly.In the meantime you can find out more about us here.
- [GA - Medical device service UK EU - Thank you](https://boydconsultants.com/medical-device-regulatory-consulting-ga-thank-you/) - Thank you Thank you for your enquiry. A member of our team will be in touch shortly.In the meantime you can find out more about us here.
- [End of Phase 2 Checklist](https://boydconsultants.com/end-of-phase-2-checklist/) - This free webinar focuses on some of the most common challenges faced by biotechs, academic groups and pharma companies in the very early phases of developing drugs, whether they be small molecules, traditional biologics or advanced therapies. Dr Nick Meyers, Vice President of Product Development at Boyds, shares his insights and solutions to help overcome or avoid these challenges.
- [Regulatory Submission Pathways](https://boydconsultants.com/regulatory-submission-pathways/) - Explore global regulatory submission pathways, including Project Orbis and the Access Consortium. Boyds guides you through accelerated, collaborative routes to approval.
- [UK Clinical Trials Regulations 2025](https://boydconsultants.com/uk-clinical-trials-regulations/) - This free webinar focuses on some of the most common challenges faced by biotechs, academic groups and pharma companies in the very early phases of developing drugs, whether they be small molecules, traditional biologics or advanced therapies. Dr Nick Meyers, Vice President of Product Development at Boyds, shares his insights and solutions to help overcome or avoid these challenges.
- [Investigational New Drug Application Support](https://boydconsultants.com/investigational-new-drug-application-support/) - Expert Investigational New Drug application support for biotech and pharma. FDA-experienced consultants supporting IND strategy, submission and lifecycle management.
- [Join Us](https://boydconsultants.com/join-us/) - Boyds is a friendly, supportive and rewarding place to support your personal growth and professional career. Join us and work in the development of cutting-edge cell and gene therapies.
- [Drug Development Consulting Services](https://boydconsultants.com/services/) - We provide drug development consulting services topharma companies, biotechs, and spin-outs to support the development of new medicines for patient benefit.
- [Case Studies](https://boydconsultants.com/latest/case-studies/) - These case studies from the team at Boyds demonstrate the scope of our work and the level of expertise Boyds demonstrate at each stage of the drug development journey across a range of therapeutic areas.
- [Interim Program Management](https://boydconsultants.com/services/product-development/interim-programme-management/) - Boyds can rapidly gain a deep understanding of your drug development programme and ensure appropriate programme management tools are put in place, enabling the smooth progression of your project.
- [Integrated Program Management](https://boydconsultants.com/services/product-development/integrated-programme-management-to-accelerate-drug-development/) - Using an integrated programme management approach, and accelerating drug development. The Boyds approach.
- [Contact us - Thank you](https://boydconsultants.com/contact-us-thank-you/) - Thank you Thank you for your enquiry. A member of our team will be in touch shortly.In the meantime you can find out more about us here.
- [Regulatory Updates](https://boydconsultants.com/medicines-regulations-updates/) - In the fast-paced world of medicines regulations, Boyds keeps a close eye on the latest regulatory updates and guidance from the regulatory authorities
- [Working at Boyds](https://boydconsultants.com/join-us/working-at-boyds/) - Our team of experts enjoy working at Boyds and supporting clients in the translation of science into medicinal products. We work at the cutting-edge and think outside of the box.
- [Vision and Values](https://boydconsultants.com/vision-and-values/) - As Boyds continues to grow, we have built our business on a solid culture which is part of what makes us who we are today. As Boyds continues to grow, we have built our business on a solid culture which is part of what makes us who we are today. The welfare and health of
- [Kimberley Ormerod](https://boydconsultants.com/kimberley-ormerod/) - Kimberley Ormerod is an experienced HR professional and Chief People Officer at Boyds.
- [Sue Carr](https://boydconsultants.com/sue-carr/) - Sue Carr is an experienced marketing professional and works with Boyds as Chief Marketing Officer.
- [Neil Chakrabarti](https://boydconsultants.com/neil-chakrabarti/) - Neil Chakrabarti is Chief Financial Officer at Boyds. He is an experienced financial leader with extensive experience across the sector.
- [Dr Katherine Bowen](https://boydconsultants.com/dr-katherine-bowen/) - Dr Katherine Bowen is Chief Regulatory Affairs Officer at Boyds and leads the award-winning regulatory team.
- [Dr Nick Meyers](https://boydconsultants.com/dr-nick-meyers/) - Dr Nick Meyers is an experienced programme and project manager and Chief Development Officer at Boyds.
- [Neil Fish](https://boydconsultants.com/neil-fish/) - Dr Neil Fish is Chief Business Officer at Boyds, responsible for developing new opportunities across the UK, Europe and US.
- [Events](https://boydconsultants.com/latest/events/) - Find out which upcoming events in the life sciences industry Boyds will be attending.
- [Expertise](https://boydconsultants.com/our-expertise/) - The Boyds team has drug development expertise across a range of therapeutic areas and can provide operational and strategic input across all stages of the drug development process.
- [Latest](https://boydconsultants.com/latest/) - All of the latest news, blogs and case studies at Boyds.
- [How to de-risk your clinical development plan](https://boydconsultants.com/how-to-de-risk-your-clinical-development-plan/) - Webinar How to de-risk your clinical development plan This webinar is designed to provide you with essential strategies and insights to navigate and mitigate risks in your clinical development processes.In this webinar, Dr Karen Mullen, Chief Medical Officer, and Dr Harriet Gray Stephens, Medical Director at Boyds, discuss how to de-risk your clinical development plan
- [Early stage development: Challenges and solutions](https://boydconsultants.com/webinar-early-stage-development/) - Webinar Early-Stage Drug Development: Challenges and Solutions This free webinar focuses on some of the most common challenges faced by biotechs, academic groups and pharma companies in the very early phases of developing drugs, whether they be small molecules, traditional biologics or advanced therapies.Dr Nick Meyers, Vice President of Product Development at Boyds, shares his insights and
- [How to de-risk your IND: Strategy & planning and operational considerations](https://boydconsultants.com/webinar-how-to-de-risk-your-ind/) - Webinar How to De-Risk your IND This webinar is designed to provide a plan of action that can help to de-risk your Investigational New Drug (IND) application and expedite the path to gaining study clearance. Dr. Nick Meyers, Vice President of Product Development and Katy Rudnick, Head of US Regulatory Affairs, will take you through
- [Resources](https://boydconsultants.com/resources/) - Useful links and factsheets from the regulatory agencies and more.
- [Toxicology Consulting](https://boydconsultants.com/services/regulatory-affairs/toxicology-consulting/) - Toxicology Consulting | Boyds works with specialist toxicologists to provide the supporting tax data needed for regulatory submissions.
- [Biopharmaceutical Development](https://boydconsultants.com/services/product-development/biopharmaceutical-product-development/) - The main goal of any biopharmaceutical development program is to translate science into treatments to improve patient health. Boyds has the experience and expertise to support your journey from concept to clinic.
- [Blogs](https://boydconsultants.com/latest/blogs/) - Read all the latest blogs surrounding the drug development, life sciences and pharmaceutical industry from Boyds.
- [Thank you](https://boydconsultants.com/thank-you/) - Thank you Thank you for your enquiry. A member of our team will be in touch shortly.In the meantime you can find out more about us here.
- [Webinars](https://boydconsultants.com/latest/webinars/) - Webinars Webinar How to de-risk your clinical development plan Watch now » September 25, 2024 Webinar How to de-risk your IND: Strategy & planning and operational considerations Watch now » April 2, 2024 Webinar Early stage development: Challenges and solutions Watch now » April 20, 2023 Speak to a member of the team today Contact
- [Early-Stage Development Webinar](https://boydconsultants.com/early-stage-development-webinar/) - An early-stage development webinar focusing on some of the most common challenges faced by biotechs, academic groups and pharma companies in the very early phases of developing drugs.
- [Publications](https://boydconsultants.com/publications/) - Publications 1155. Coadministration of Intranasal M2SR (M2-deficient Single Replication) Investigational Influenza Vaccine with Fluzone High Dose Induces Superior Immune Responses to Fluzone High Dose Alone in 65-85 Year Old Adults Open Forum Infect Dis Published December 2023 by Dr Bryan Murray Click here to read the full Publication Development and usability testing of an electronic
- [Factsheets](https://boydconsultants.com/latest/factsheets/) - Factsheets Factsheet Clinical Trials with Genetically Modified Organisms (EU) Download now » February 14, 2024 Factsheet Regulation of medical and in vitro diagnostic medical devices in the UK (Great Britain and Northern Ireland) Download now » February 14, 2024 Factsheet Scientific advice (US-FDA) Download now » February 14, 2024 Factsheet Preparing for the Clinical Trials
- [News](https://boydconsultants.com/latest/news/) - Stay up to date with all latest news and insights from Boyds.
- [Boyds Newsletter Sign Up](https://boydconsultants.com/sign-up/) - Sign up to the Boyds newsletter and receive all the latest updates from Boyds, updates from the regulatory agencies and more.
- [Pharmaceutical Project Leadership](https://boydconsultants.com/services/product-development/pharmaceutical-project-leadership/) - Experienced Leadership to Drive your Drug Development Project Forward Engaging an experienced Pharmaceutical Project Leader who has delivered drug programmes through the various stages of the development pipeline improves the likelihood of effectively navigating the potential challenges. The team at Boyds initiate the required discussions at the right time within the project team and know

## Categories

- [News](https://boydconsultants.com/category/news/)
- [Blog](https://boydconsultants.com/category/blog/)
- [Case Study](https://boydconsultants.com/category/case-studies/)
- [Vacancies](https://boydconsultants.com/category/vacancies/)
- [Webinar](https://boydconsultants.com/category/webinar/)
- [Google Ads landing page](https://boydconsultants.com/category/google-ads-landing-page/)
- [Meet the Medic](https://boydconsultants.com/category/meet-the-medic/)
- [Factsheet](https://boydconsultants.com/category/factsheet/)
- [Publishing](https://boydconsultants.com/category/publishing/)
- [Regulatory Affairs](https://boydconsultants.com/category/regulatory-affairs/)
- [Podcast](https://boydconsultants.com/category/podcast/)

## Tags

- [Due Diligence](https://boydconsultants.com/tag/due-diligence/)
- [TPP](https://boydconsultants.com/tag/tpp/)
- [medical director blog](https://boydconsultants.com/tag/medical-director-blog/)
- [Factsheet](https://boydconsultants.com/tag/factsheet/)
- [Clinical & Medical](https://boydconsultants.com/tag/clinical-medical/)
- [Webinar](https://boydconsultants.com/tag/webinar/)
- [Meet the Medic](https://boydconsultants.com/tag/meet-the-medic/)
- [CGT](https://boydconsultants.com/tag/cgt/)
- [Biotech start-up support](https://boydconsultants.com/tag/biotech-start-up-support/)
- [CTD](https://boydconsultants.com/tag/ctd/)
- [Phase II](https://boydconsultants.com/tag/phase-ii/)
- [EOP2](https://boydconsultants.com/tag/eop2/)