Cathy Burgess

FDA-regulated entities benefit from Cathy’s common-sense advice for achieving business objectives that avoid compliance and enforcement risks. With more than 30 years of extensive experience in the areas of CGMP regulation and product risk management, she has provided strategic counseling and works with multinational clients to identify and address potential risks throughout the product life cycle. She focuses her practice on regulatory compliance, product risk management, enforcement, and policy matters affecting industries regulated by the FDA.

Food and Drug Law Institute, board of directors (2018-2022); Food and Drug Law Institute, Audit Committee, in-house training team to FDA; Parenteral Drug Association; Food and Drug Law Institute, 2023 FDLI Distinguished Service and Leadership Award recipient.