Regulatory Affairs Consulting
Facilitating the efficient development of medicinal products with the FDA, EMA, MHRA and global regulatory agencies
Our award-winning Regulatory Affairs team has built long-standing, trusted relationships with multiple leading regulators including the FDA, EMA and MHRA.
These relationships are founded on decades of experience and recognized for enabling productive, solution-focused discussions that move development forward.
Boyds’ unique combination of hands-on regulatory experience and comprehensive scientific expertise helps accelerate your path from development to approval.
We are highly flexible and can work with you in whatever way best fits your needs — whether leading regulatory strategy within your project team or supporting your existing staff with thoughtful, well-researched input and up-to-date regulatory expertise.
Our consultants have extensive experience across diverse therapeutic areas and all stages of development. Renowned for our work in advanced and novel therapies, we also provide comprehensive regulatory support for small molecules and biologics, ensuring every program benefits from our depth of scientific and strategic insight.
We’re here for every step of your regulatory journey, from defining strategy to preparing and submitting documentation, managing communications with regulators, and guiding you through each procedure to help bring your product closer to patients in need.
Core regulatory affairs services
We provide strategic, hands-on support across the full regulatory lifecycle, including:
- Regulatory strategy & gap analysis
- CMC, non-clinical & clinical expertise
- Clinical trial (CTA) / investigational new drug (IND) applications (EU, US, UK)
- Agency meetings / including early interactions, formal Scientific advice meetings and advisory committees
- Pediatric development strategies and submissions
- Marketing authorization applications (MAA, NDA, BLA) (EU, US, UK)
- Lifecycle management (EU & US)
- Environmental risk assessments
Global regulatory expertise
Our team has extensive experience coordinating with the FDA, EMA, and MHRA, delivering successful outcomes in:
- Early Development & Pre-Application
- Pre-IND correspondence & IND applications
- Early regulatory interactions
- Clinical Trial Applications (CTAs)
- FDA Pediatric Study Plans (iPSP/PSP) and EMA/MHRA Pediatric Investigation Plans (PIP)
- Orphan Drug Applications – Read our ODD factsheet (FDA) or ODD (EMA)
- Expedited Designations
- Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT) designation applications (FDA)
- PRIME scheme requests (EMA)
- PIM designation, EAMS, and ILAP applications (MHRA)
- Marketing Applications
- NDA, BLA, and MAA submissions (EU, UK, US)
- GMO submissions – Read our factsheet
Our Regulatory Affairs specialists work closely with our Medical Writing team to prepare high-quality submissions, briefing documents and regulatory correspondence that meet the expectations of global health authorities. Together, we ensure every detail supports a clear, strategic and compliant pathway to approval.
Looking for end-to-end submission support?
Looking to file in the US?
Expertise with FDA IND, NDA & BLA submissions
Find out moreLooking to file in the UK or Europe?
Specialist support for EMA, MHRA & national submissions
Find out moreInvestigational New Drug Application Support
Success stories
Ready to move your program forward?
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.