Regulatory Strategy
& Implementation

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

• Regulatory pathway strategy, content compilation of INDs, NDAs, BLAs, and MAAs, as well as process 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)

TBG shared its views on the FDA’s proposed guidance for the implementation of penalties for non-compliance with existing clinical study results reporting obligations. TBG proposed a solution that allows clinical trial sponsors to verify that reporting requirements have been met.

In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.

TBG responded to the draft guidance giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.

Bracken Data’s TrialCompliance Lite provides a fast and easy way to ensure your data in ClinicalTrials.gov is compliant with all current requirements. In three easy steps you can determine if your company's trial is compliant or not.

• Simply enter the NCT number of a trial
• Our system checks the trial criteria against FDA guidelines
• TrialCompliance Lite tells you if the trial is compliant or non-compliant