US companies looking to file in the US
Boyds takes a strategic and holistic view to adopt the best route to accomplish our clients’ goals including expedited roads of review/approval (Priority, Breakthrough, Accelerated, and Fast Track pathways) and patient access.
Our team has the extensive expertise needed to help clients navigate the whole pathway from concept, to bench, to patient. Alongside this expertise is our reputation with the regulatory agencies, key opinion leaders and other professionals in the industry as well as our network of specialists, which makes us an ideal partner for clients looking for support at any part of their process.
The reputation held by the team, due to its depth of experience, enables Boyds to successfully navigate the application process for new treatments where regulations and precedent have not yet been established. Boyds holds a strong relationship with the FDA, MHRA, and other national authorities to negotiate an approvable product.
This unique position helps us to help our clients with the support needed to facilitate the fast and efficient development of the product. The Boyds’ regulatory team is skilled in the laws and precedent of the US pharma/device areas and processes the tact, discretion and confidence to lead agency discussions and successfully negotiate the sponsors’ position. The Boyds team can guide filings in the US and abroad and many times supports tandem applications.
We have extensive experience in strategic planning, agency coordination and negotiation, compilation, submission and lifecycle management of:
- Pre-application correspondence (pIND)
- IND and CTA Applications
- Orphan Drug Applications
- Pediatric Investigation/Study Plans (iPSP and agreed PSP)
- Fast Track, Breakthrough and Regenerative Medicines Advanced Therapy Designation Applications
- PRIME Scheme Requests
- PIM Designation, EAMS and ILAP Applications
- NDA/BLA/MAA
- GMO Submissions
- Environmental Risk Assessments
Boyds’ team can assist clients in obtaining scientific advice from the FDA to ensure that maximum benefit is derived from the interaction, and we:
- Advise on strategy, and prepare draft questions and briefing documents
- Liaise with the FDA to arrange the meeting
- Represent the client at the meeting
- Prepare meeting minutes and follow up on any issues
