Looking to file in the US?
Boyds guides global biotech and pharmaceutical companies through successful FDA submissions – helping you navigate IND, NDA, and BLA pathways with confidence.
Why partner with Boyds
- Significant experience as direct liaison with FDA stakeholders
- 20+ years of regulatory experience
- Experience across IND, NDA, BLA and orphan programs
Filing in the US can be complex, especially if you’re based outside the region. We help you navigate the FDA submission process with clarity and confidence, ensuring your application meets regulatory expectations.
Our team has the extensive expertise needed to help you navigate the entire pathway from concept, to bench, to patient. With strong relationships across US FDA regulators, key opinion leaders, and our network of specialists, we’re the ideal partner to support you throughout your lifecycle development.
We help identify regulatory opportunities and risks through early gap analysis, ensuring your data packages and development plans are aligned with FDA expectations before submission.
- Experience with novel and advanced therapies
With decades of collective experience, we guide you through applications for innovative new drugs, biologics, and advanced medicinal products, including cell and gene therapies and gene-edited products – even in areas where guidance or precedents have yet to be established. Our deep expertise allows us to identify creative, compliant solutions that move your development forward with confidence.
At Boyds, we take a strategic and holistic view to adopt the best route to achieve your goals, including expedited pathways such as Priority, Breakthrough, Accelerated, and Fast Track reviews, to bring treatments to patients faster. We further leverage robust FDA communication to best de-risk each lifecycle development milestone.
We have extensive experience in strategic planning, agency coordination and negotiation, compilation, submission and lifecycle management of:
- Pre-application correspondence (INTERACT and Pre-IND meetings) – helping ensure your program is “Safe to Proceed” to first-in-human studies.
- IND applications and lifecycle development
- IND maintenance and lifecycle reporting, including Annual Reports and Development Safety Update Reports (DSURs).
- Orphan Drug Designations
- Pediatric Study Plans (iPSP/PSP)
- Fast Track, Breakthrough and Regenerative Medicine Advanced Therapy Designation applications
- NDA and BLA submissions
- GMO Submissions
- Environmental Risk Assessments
- Formal FDA meeting facilitation
- Electronic publishing through the Electronic Submissions Gateway.
- Strong relationships with regulators
Boyds maintains respected, long-standing relationships with FDA stakeholders across both CDER and CBER. This has been built upon prior and ongoing support for investigational product lifecycle development and licensure activities, as well as direct interaction with FDA regulatory project managers and disciplinary reviewers.
- Trusted US Agent / Sponsor’s Authorized Representative
Our Regulatory Affairs team brings tact, discretion, and confidence to agency discussions, ensuring your position is clearly represented. With experts based in the United States, we can act as your US Agent, providing direct FDA liaison and legal standing.
We routinely guide filings in the US and internationally, often supporting parallel or tandem applications to accelerate global access. In addition, we frequently assist companies whose programs originated outside the US, helping to bridge regional data, adapt documentation, and align submissions with FDA expectations to ensure a smooth market entry.
- FDA meeting preparation and representation
Our team can help you get the most value from your interactions with the FDA, having directly facilitated hundreds of FDA meetings. We:
- Advise you on meeting type and strategy, and prepare meeting requests, questions, supportive positions, and briefing packages
- Coach and prepare your team for the FDA meeting
- Function as your direct representative, leading your FDA interaction
- Prepare official meeting minutes and follow-up actions, and advise on next steps
As part of this process, our Regulatory Operations & Publishing team ensures your FDA submissions are formatted and validated through the Electronic Submissions Gateway for seamless review.
Back to Regulatory Affairs
Back to Regulatory Affairs
Looking to file in the UK or Europe?
Specialist support for EMA, MHRA & national submissions
Find out moreReady to take your product to the US market?
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.