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.
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