U.S. Agent

Primary role is to communicate directly with US FDA on behalf of a sponsor. For companies that do not have […]

Gap Analysis

An objective evaluation of a product in the context of a company‚Äôs stated goal (e.g., NDA submission). The gap analysis […]

Medical Writing of Submission Documents

Authoring and coordination of cross-functional reviews for regulatory submission documents including competitive product labeling content and risk management in the […]