Regulatory Strategy
& Implementation

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.

• 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)

In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.

Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.