FDA regulations expert witnesses analyze whether drugs, devices, and biologics comply with federal requirements across development, approval, labeling, and postmarket surveillance. Drawn from regulatory affairs, pharmacology, clinical research, and quality systems, they evaluate adherence to FDA guidance, Good Manufacturing Practices, reporting duties, and risk management processes.
Pharmaceutical Quality & FDA Regulatory Compliance Expert Witness
Pharmaceutical Quality & FDA Regulatory Compliance Expert Witness
- Review Fee
- $250/hr
- Deposition Fee
- $500/hr
- Court Fee
- $500/hr
This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.
Founder/Principal, A consulting services for pharmaceutical firms
Master of Business Administration (MBA), Temple University
Savannah,
Georgia