StrataCore’s regulatory team is led by Brian Harvey MD PhD.  Dr. Harvey recently served as VP of US Regulatory Strategy for Pfizer, covering drugs and biologics across all therapeutic areas in the U.S., as well as regulatory liaison for global medical devices.  Previously, he was VP of U.S. Regulatory Policy for Sanofi, including the merger with Genzyme.  Dr.  Harvey has over 11 years of FDA experience in the Centers for Drugs, Biologics, and Devices in both medical officer review and management positions.  He has experience in drug, biologic product, medical device and combination product pre-market regulatory evaluation. 

Brian Harvey Resume

SERVICE LIST

•  FDA engagement strategy
•  Clinical Development Plan Review & Implementation
•  Health Agency Interaction Coaching
•  Corporate Strategic Planning
•  Venture Capital Due Diligence Analysis