Regulatory Affairs

Regulatory success takes strategy, relationships, and experience in the room

Bracken brings all three, from first FDA contact to commercial approval.

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Our team has filed BLAs and NDAs, led CMC strategy at BeiGene, and prepared clients for pre-IND, EOP2, pre-NDA, AdCom, and CPIM meetings alike.

5 Senior consultants carrying regulatory affairs expertise
6 FDA meeting types covered, pre-IND through AdComs and CPIM
FDA & EMA Direct agency engagement, not just paper strategy

What We Do

Bracken's regulatory affairs consultants guide development teams from initial health authority contact through NDA, BLA, and MAA approval, across therapeutic areas including cardiovascular, CNS, and oncology programs.

  • Regulatory strategy development and content compilation for INDs, NDAs, BLAs, and MAA filings
  • FDA meeting preparation, including pre-IND, EOP2, pre-NDA, AdComs, CPIM, and VxD meetings
  • Written and face-to-face FDA communications throughout the development program
  • CMC regulatory strategy for small and large molecule products, including IMPDs and CTAs
  • Comparability protocols and amendments, and labelling negotiation
  • Orphan drug submissions and designation strategy
  • US Agent support for regulatory functions based outside the United States
  • EMA scientific advice meetings alongside FDA formal meetings
  • Interim Head of Regulatory Affairs, Regulatory Director, or Regulatory Manager placement
  • Regulatory intelligence and ClinicalTrials.gov study results registration compliance

Bracken is a concierge-style life sciences consultancy, and its regulatory consultants are regularly asked to step in as an interim Head of Regulatory Affairs, Regulatory Director, or Regulatory Manager during a search for full-time hires. Hear Senior Regulatory Consultant Liz Bloss discuss FDA relationships on Fractals: Life Science Conversations. This work sits alongside our Radiopharmaceutical Strategy & Operations and Functional Service Provider practices.

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Our Consultants

Senior regulatory consultants with FDA, EMA, Health Canada, and CMC experience across small and large molecules.

Meet the Team

Our Publications

Peer-reviewed publications and scientific accomplishments from the consultants who would work on your program.

Browse Publications

Client Case Studies

Published regulatory engagements, from restoring regulatory continuity to due diligence ahead of acquisition.

Case Study Library
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Questions

What does regulatory affairs consulting cover at Bracken?
Regulatory strategy and content compilation for INDs, NDAs, BLAs, and MAAs, submission processes through approval, FDA meeting preparation, CMC regulatory strategy, orphan drug submissions, and interim regulatory leadership. Engagements run from a single advisor on one FDA meeting to a fractional Head of Regulatory Affairs role for the length of a program.
Can Bracken serve as our Interim Head of Regulatory Affairs?
Yes. Bracken places consultants as an Interim Head of Regulatory Affairs, Regulatory Director, or Regulatory Manager to keep a program moving during a search for full-time hires. This runs through the same fractional model as our other Functional Service Provider engagements, and can scale up or down as the program's needs change.
Which FDA meeting types does Bracken prepare clients for?
Pre-IND, End-of-Phase 2 (EOP2), pre-NDA, Advisory Committee (AdCom) meetings, Critical Path Innovation Meetings (CPIM), and Voluntary Exploratory Data Submissions (VxD). Use the FDA Meeting Request Calculator to get a complete response and meeting timeline for your specific meeting type.
Does Bracken support EMA and other health authorities, not just the FDA?
Yes. Alongside FDA formal meetings, Bracken supports EMA scientific advice meetings, and has prepared, submitted, and negotiated product submissions with Health Canada and the EPA. US Agent support is available for companies whose regulatory function sits outside the United States.

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Let's map out where your regulatory strategy needs to go next.

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