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Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11.


Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition, consultant now has worked for over 14 years as a consultant assisting firms in preparing strategies and documents for submission to FDA throughout all phases of development.

Over 25 years of experience in all aspects of drug, device and biolgoic product development, including INDs, NDA, BLA, PMA and product regulation.


Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition, consultant now has worked for over 14 years as a consultant assisting firms in preparing strategies and documents for submission to FDA throughout all phases of development.

Member of DIA. former Editor in Chief of Journal.
editorial board - Global Forum

Basic research training in experience in pharmacology and toxicology and all aspects of mechanism of action of drugs.


1985 to 1990, expert worked as a reviewer in the Center for Drug Evaluation & Research at the FDA, in the Divisions of Antiviral Drug Products, Oncologic Drug Products, and the Division of Bioequivalence. As an FDA reviewer, he participated in numerous preclinical and clinical drug development review projects for generic drugs and drugs for serious and life-threatening illnesses. He also served as primary pharmacology/toxicology reviewer for hundreds of INDs and NDAs for cancer, AIDS and AIDS-related drugs. He reviewed over 200 bioequivalence studies for generic versions of major drug products and proposed and drafted guidelines for bioequivalence study requirements for a number of therapeutic classes. While at the FDA he also drafted a number of Agency documents and position papers on the issues of bioequivalence and generic drugs. Expert wrote a major policy paper on the FDA's position on bioequivalence that was published in a peer reviewed journal, for industry-wide dissemination. Expert organized the FDA Bioequivalence Hearing, including assisting in agenda planning and speaker selection and later drafted the landmark Task Force Report on Bioequivalence for the Commissioner's office.