Dr. Sharon A. Segal

Director of Regulatory Science

Sharon A. Segal, Ph.D. is the director of regulatory science for the FDA/Healthcare Regulation Practice. Dr. Segal provides scientific and regulatory consulting services to both domestic and international companies on FDA-regulated products.

Dr. Segal has an extensive background in pharmacology, physiology, and toxicology, and in developing and managing regulatory pathway strategies, jurisdictional disputes, product development plans, preclinical and clinical testing programs, regulatory submissions, and product defense strategies for medical devices, drugs, biologics, foods, food additives, and dietary supplements. She also has participated in due diligence assessments to evaluate potential product acquisitions regarding regulatory, scientific, and marketing issues; supported preparation of FDA Advisory Committee presentations; participated in the preparation of reclassification and citizens petitions and responses to proposed FDA rules; and evaluated promotional materials for FDA-regulated products with regard to compliance with FDA laws and regulations.

Dr. Segal also has provided litigation support and advice to counsel with respect to Class III medical devices, encompassing the communication of scientific issues in public and legislative forums, expert witness identification and development, and critical analysis of relevant literature.

Dr. Segal has given numerous presentations and moderated panel discussions at scientific and regulatory meetings both in the U.S. and abroad. She has published over 20 articles in areas such as the clinical testing of medical devices, the regulation of medical devices and biologics, and the toxicology of environmental contaminants.

Dr. Segal earned her Ph.D. in pharmacology from the Georgetown University School of Medicine in 1982, and completed a post-doctoral fellowship in physiology and pharmacology at the Uniformed Services University of the Health Sciences. She received her B.S. in biology from Franklin and Marshall College in 1978.