Toxicology & Regulatory Science Associates, LLC

 

 

 

 

Dr. Brenda Seidman is TOX-RSA’s principal consultant and founder.   With over 20 years of experience as a regulatory toxicologist, she has repeatedly demonstrated her strong analytical, scientific problem solving and communication skills. Dr. Seidman specializes in small molecule pharmaceuticals, biologics, medical devices, combination products, risk assessment, neurotoxicology, and data integrity issues, including those related to the Good Laboratory Practice regulations (21 CFR Part 58).   Her professional experience includes time spent as a reviewer at FDA’s Center for Drug Evaluation and Research, where she evaluated submissions of small molecule pharmaceuticals (Division of Metabolism and Endocrinology Products) and biologics (Division of Biologic Oncology Products). In CDER, she also reactivated and co-chaired its pharmacology/toxicology Neurotoxicity Assessment Subcommittee. Before joining FDA, Dr. Seidman was a consultant in the area of medical device and medical device-drug combination product toxicology and biocompatility.   She was trained in general toxicology and neurotoxicology at University of California, Los Angeles’ (UCLA’s) School of Public Health where she received both her M.S. and Ph.D., and she was a postdoctoral research fellow in University of California, San Francisco’s (UCSF’s) Department of Neurology. She is a member of the Society of Toxicology.