Pharmaceutical Industry Expert

This pharmaceutical industry expert has more than 15 years of experience working as a strategic consultant providing services for the biotechnology, pharmaceutical and biopharmaceutical industries. In his early career, he held several executive roles in research and development at pharmaceutical companies. As president of a consulting firm, he currently aids clients in the manufacturing process of pharmaceutical products. In this role, he has reviewed quality assurance and prepared documentation for submission to the Food and Drug Administration (FDA), as well as many international regulatory agencies. He has evaluated compliance of pharmaceutical regulations on products in all clinical trial stages for some of the nation’s largest pharmaceutical corporations.

• Testified in deposition
• Consulting

• More than 20 years of experience in the pharmaceutical industry
• Professional organizations include the American Association of Pharmaceutical Scientists (AAPS), the American Chemical Society (ACS), the Parenteral Drug Association (PDA), the Drug Information Association (DIA) and the International Society of Pharmaceutical Engineering (ISPE)
• Intimate familiarity with pharmaceutical regulations and guidelines of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the International Conference on Harmonisation (ICH)
• Recipient of a graduate training grant and undergraduate research grant awarded by the National Institutes of Health (NIH)

• Ph.D., Biochemistry
• B.A., Chemistry

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