Zi-Qiang Gu, PhD Pharmaceutical Consultant

Dr. Gu has over fourteen years of experience working with FDA regulations, guidance, procedures in the area of Chemistry, Manufacturing and Controls (CMC) and Current Good Manufacturing Practice (CGMP), as well as six years of experience in drug research and development in the pharmaceutical industry. He has extensive CMC and CGMP knowledge and experience in different phases of drug discovery, development and commercial manufacturing, and drug application submissions.

Dr. Gu received his PhD in Synthetic Organic and Medicinal Chemistry in 1990 from Rutgers University. As a National Research Council postdoctoral fellow, he conducted research in the fields of medicinal chemistry and neuropharmacology at the National Institutes of Health (NIH) before he moved to pharmaceutical industry. He worked as a research scientist and project/group leader in pharmaceutical industry in the area of drug design, drug synthesis and process development.

He joined the FDA as a review chemist in the Center for Drug Evaluation and Research (CDER) in 1998. His responsibility in FDA includes reviewing, evaluating, and writing technical reviews of the chemistry, manufacturing and controls sections of New Drug applications (NDA), Investigational New Drug (IND) and Post-approval Chemistry Supplements. In 2004, he moved to FDA CDER Office of Compliance, Investigational and Pre-Approval Branch as a compliance officer, responsible for compliance review of drug substance and drug product manufacturing facilities for CGMP compliance, as well as participating in pre-approval and GMP inspections.

Dr. Gu has authored/co-authored over 50 peer reviewed scientific papers, patents and abstracts, and given over numerous invited presentations. Dr. Gu has received numerous awards from FDA including Special Recognition Award for Quality Contribution to the Review and Approval of New Drug Application, Regulatory Excellence Award and FDA Commissioner’s Special Citation for extraordinary achievements. Currently, Dr. Gu serves as a CMC and GMP consultant for pharmaceutical industry.