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In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in

Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.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


Bracken Welcomes New Consultants Deepak Behera, MD, and Gitte Andreasen, Providing Expertise in Radiopharmaceuticals and Marketing, Respectively.

NEWTOWN, PA. 8 February, 2023. — The Bracken Group announces the addition of Dr. Deepak Behera,..

Supporting Biotech and Pharma Companies Using Imaging Endpoints in Clinical Trials

Click here to open a PDF version of this case study The use of imaging endpoints in clinical trials..

Ask us anything.

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.