EXPERTISE

Regulatory Strategy
& Implementation

Helping you navigate health authority interactions.

Bracken’s collective drug and product regulatory experience helps companies avoid costly delays and unnecessary investor and partner risk. Our experts help development teams from initial filing through regulatory approval.

Multi-layered guidance.

  • Regulatory pathway strategy, content compilation of INDs, NDAs, BLAs, and MAAs, as well as process assistance for submission of INDs, NDAs, BLAs, and MAAs
  • Written and face-to-face communications with the FDA and EMA
  • FDA meeting preparation for pre-IND, EOP2, pre-NDA, AdComs, and “Clinical Path for Innovation meetings” (CPIM) as well as Voluntary Exploratory Data Submissions (VxDs) meetings
  • Interim Head of Regulatory Affairs role for clients to allow for a smooth transition process during search for full-time regulatory staff
  • Therapeutic areas (i.e. oncology, CNS, cardiovascular)

Compliance with ClinicalTrials.gov study results registration requirements.

In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.

Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.

Learn more about our regulatory expertise.

We have extensive experience in guiding development teams and investors from initial filing through regulatory approval.

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NEWTOWN, PA. 25 October 2022. —The Bracken Group is pleased to announce that Dr. Alexander “Sandy”..

The Bracken Group Named Best Digital Health Marketing Agency of the Year 2022 by Global Health and Pharma

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We would be delighted to hear from you and discuss our consulting services. Please call +1 215 648 1208 to chat with us directly. Or write to us using the form provided here. We look forward to collaborating with you.