Primary role is to communicate directly with US FDA on behalf of a sponsor. For companies that do not have […]
An objective evaluation of a product in the context of a company’s stated goal (e.g., NDA submission). The gap analysis […]
Generation and review of a carefully designed regulatory plan (clinical, nonclinical, CMC and procedural activities) that must be accomplished to […]
Authoring and coordination of cross-functional reviews for regulatory submission documents including competitive product labeling content and risk management in the […]
A detailed review of the scientific basis and regulatory compliance of submission content.
Management of the creation, review and finalization of regulatory submissions (e.g., INDs, NDAs/BLAs).