Durham, North Carolina
Pharmaceutical Regulation Expert Witness
FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration, regulatory affairs practice, FDA regulated industry, submissions/dossiers, labeling, compliance.
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters.
Education: M.S. Physiology, Florida State University, 1968.
B.A. Biology, Woman's College of the University of North Carolina, 1963.
Years in Practice: 35+
Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.
Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.
Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.
Member of the Scientific Advisory Board for BioLink Sciences, Inc.
Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professiona...