Judy F. Gordon

President

ClinReg Consulting Services, Inc.
Laguna Beach, CA

Judy F. Gordon , D.V.M., founder, and president of ClinReg Consulting Services, Inc., a firm founded to assist medical device companies with clinical and regulatory issues. ClinReg's Services include clinical protocol development, meetings with FDA, IDE and IND submissions, HUD and HDE submissions, premarket notifications, PMAs, and NDAs. Specialized services include preparation for Advisory Committee review of PMAs/NDAs, management of Data Safety and Monitoring Boards (DSMBs), review and reporting of adverse events, and preparation for FDA bioresearch monitoring. Dr. Gordon has taken multiple PMAs and NDAs through the FDA review process, and has directed large-scale clinical trials of both devices and pharmaceutical products. Prior to ClinReg, Dr. Gordon was with Chiron Vision, a division of Chiron Corporation, from the company's founding in 1986 through its acquisition by Bausch & Lomb in 1997. At Chiron Vision, Dr. Gordon served as Senior Vice President of R&D and as Vice President of Scientific Affairs, with responsibility for product development, clinical research, regulatory affairs, and regulatory compliance. In her consulting practice, Dr. Gordon has been involved in the development, clinical and regulatory activities for a broad range of products. Dr. Gordan served as the industry representative to FDA's Ophthalmic Devices Advisory Panel, and as the industry representative to the Mediation Dispute Panel of the Center for Devices and Radiologic Health.