Looking to file in the UK or Europe?
Boyds provides strategic regulatory support for MHRA and EMA submissions — helping you navigate CTA, MAA, and PRIME pathways with clarity and confidence.
Filing in the UK and Europe can be complex, especially as regulatory frameworks evolve post-Brexit.
We help you navigate MHRA and EMA requirements, ensuring your submissions are well-prepared, compliant, and strategically aligned for approval.
Why partner with Boyds
- Dual presence in the UK and Europe
- 20+ years of EMA and MHRA experience
- Experience with MAA, CTA, PRIME, and Orphan Drug Designations
Boyds has significant experience in successful interactions with the EMA’s CHMP, EU national agencies, and the UK’s MHRA for cutting-edge medicinal treatments and technologies.
We work closely with you to understand and advise on regulatory strategy for interactions at all stages of drug development.
Strategic regulatory support across the UK and Europe
Boyds provides comprehensive regulatory guidance for companies seeking to file within the UK and European markets. Our team supports the full lifecycle of regulatory activities – from scientific advice and clinical trial applications to marketing authorization and post-approval maintenance.
Our experience covers both traditional and advanced therapy medicinal products (ATMPs), including biologics, cell and gene therapies, and orphan medicines.
We work closely with the MHRA and EMA to align submission strategies, minimize procedural complexity, and ensure a smooth pathway to approval.
As a recognized EMA Small and Medium-sized Enterprise (SME), Boyds can also help eligible companies access reduced fees and additional agency support – learn more.
We have extensive experience in:
- Clinical Trial Applications (CTA)
- Scientific Advice (MHRA and EMA)
- Pediatric Investigation Plans (PIPs)
- PRIME Scheme Requests
- Marketing Authorization Applications (MAA)
- Orphan Drug Designations
- Environmental Risk Assessments
- Experience where precedent doesn’t exist
With decades of collective experience, Boyds has built trusted, long-standing relationships with both the MHRA and EMA. Our regulatory consultants bring a blend of scientific expertise, strategic insight, and practical understanding of evolving European frameworks.
We are known for enabling productive, solution-focused discussions with regulators – helping you move development forward even when precedents are limited or guidance is emerging.
Boyds’ dual presence in the UK, Europe, and the US enables a unified approach to global regulatory planning.
Our consultants coordinate cross-agency interactions, helping you align submission strategies and optimize development timelines across multiple jurisdictions.
Regulatory meeting preparation and representation
Our team can help you get the most from your interactions with regulatory authorities. We:
- Advise on meeting strategy and prepare draft questions and briefing documents
- Liaise directly with the MHRA and EMA to arrange meetings
- Represent you during agency discussions
- Prepare official meeting minutes and manage follow-up actions
Back to Regulatory Affairs
Back to Regulatory Affairs
Looking to file in the US?
Expertise with FDA IND, NDA & BLA submissions
Find out moreReady to move your program forward in Europe?
Speak to our award-winning regulatory team today.
UK: +44 (0)1270 270010
US: +1 800 982 7431
Email: info@boydconsultants.com
Get in touch
If you’d like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we’ll get back to you.