A pharmaceutical regulatory compliance expert witness with more than 35 years of experience in the pharmaceutical and pharmaceutical packaging industries, this chemist specializes in regulatory compliance, laboratory management, and quality systems governing drug development and manufacturing. Credentials include a B.A. in Chemistry, an M.S. in Physical Chemistry, and an M.B.A. in Marketing and Finance. The expert’s work focuses on regulatory and technical issues involving federal drug regulatory requirements, pharmaceutical manufacturing processes, packaging component compatibility, and analytical laboratory practices. The expert has served as an expert witness providing consultation, expert reports, and deposition testimony in matters involving pharmaceutical development, regulatory compliance, and related technical issues.

His professional experience includes leadership of an independent consulting practice specializing in pharmaceutical regulatory compliance, pharmaceutical development processes, and laboratory operations. Prior roles include service in a senior scientific leadership position within a federal regulatory laboratory, overseeing teams of chemists and microbiologists responsible for analysis of pharmaceutical and food samples, participation in regulatory inspections, and review of investigation reports.

Earlier industry positions included technical roles related to pharmaceutical packaging systems and associated analytical testing, where work involved analytical testing methods, product and packaging compatibility evaluation, and coordination of regulatory interactions related to pharmaceutical packaging components. The expert’s work also includes development of Chemistry, Manufacturing and Controls (CMC) documentation, implementation of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), quality audits, corrective and preventive action programs, stability testing protocols, and laboratory procedure development. Litigation-related experience includes analysis of pharmaceutical manufacturing practices, regulatory compliance issues, and product development processes associated with pharmaceutical products and related technologies.