EXPERTISE

Regulatory Strategy
& Implementation

Helping you navigate health authority interactions.

Bracken’s collective regulatory experience helps companies avoid costly delays and unnecessary risks. Our experts help development teams from initial regulatory authority contact including pre-IND communications, IND submission to NDA submissions and filing through regulatory approval.

Multi-layered guidance.

  • Regulatory development strategy, content compilation of INDs, NDAs, BLAs, and MAAs, as well as assistance with submission processes of INDs, NDAs, BLAs, and MAAs
  • Written and face-to-face communications with the FDA
  • 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, Regulatory Director, or Regulatory Manager role for clients to allow for a smooth transition process during search for full-time regulatory team members
  • Therapeutic areas (i.e. cardiovascular, CNS, oncology)

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In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.

Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.

Transform your CRM into a life science intelligence platform.

Bracken's Clinical Trials for HubSpot and Salesforce integrates public clinical trial data into your CRM, adding unique search functions, reporting capabilities, and automation.

No separate software, no downtime for a learning curve – just clean data that drives business.

Schedule a demonstration to learn how Clinical Trials for HubSpot & Salesforce can work for you.

Learn more about our regulatory expertise.

We have extensive experience in guiding development teams from initial regulatory authority contact including pre-IND communications, IND submission to NDA submissions and filing through regulatory approval.

RECENT NEWS

Bracken Announces Consultants Ben Mitchell & Kurt Mueller

For Immediate Release: NEWTOWN, PA — The Bracken Group (Bracken) is pleased to announce the..

New Consultants Andrew Beck, Ina Rijnhout, & Martin Collyer

For Immediate Release: NEWTOWN, PA — The Bracken Group (Bracken) is pleased to announce three new..
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