Bret Andre MS

Principal Consultant for Andre Vision and Device Research (AVDR), Bret James Andre, has over 15 years of experience in regulatory affairs in the ophthalmic industry. Specializing in contact lenses and contact lens care products, AVDR offers regulatory consulting services—including strategy at early product development, identification of essential data and documentation requirements, contract research organization (CRO) services for human clinical trials, preparation of the premarket application to the United States Food and Drug Administration (FDA), and strategic interface with FDA reviewers until approval or premarket clearance. Additionally, AVDR offers consulting services for manufacturers with approved or cleared devices to ensure post market compliance. Mr. Andre has assisted ophthalmic medical device manufacturers obtain FDA premarket clearance or approval in the United States and throughout the world—including manufacturers in Taiwan, South Korea, United Kingdom, and Europe.