Regulatory affairs expert witnesses draw on careers in pharma, biotech, medical devices, and healthcare products to clarify compliance with FDA, EMA, and other regulatory frameworks. They evaluate submissions, labeling, quality systems, post-market surveillance, and risk management, and assess whether regulatory strategies, documentation, and decisions met applicable standards.
FDA Regulatory Policy and Congressional Oversight Expert Witness
FDA Regulatory Policy and Congressional Oversight Expert Witness
- Review Fee
- $500/hr
- Deposition Fee
- $500/hr
- Court Fee
- $500/hr
This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.
President, A Biotech Consultancy
Master of Science (MS), University of Texas at Austin
Milwaukee,
Wisconsin