David Lin, PhD, MBA

Consultant

Dr. Lin is President of TS Pharma Experts LLC, an independent regulatory CMC (quality) consultant with expertise in FDA requirements for the development of pharmaceutical products.

He has over 26 years of pharmaceutical regulatory experience in the technical, quality, GMP and regulatory requirements for chemical (small molecule synthetics), biopharmaceutical (biotechnological and biological) and combination product development. He currently provides regulatory and technical assistance to biotech and pharmaceutical companies that are planning to conduct clinical studies and to obtain approval for the marketing of prescription products (drugs and biologics) in the United States. This includes INDs, NDAs, ANDAs and BLAs (both innovative and biosimilar).

He received his Ph.D. in organic chemistry in the area of protein chemistry in 1989 and a M.B.A. in 2002. Dr. Lin’s regulatory product development expertise was developed at FDA while working as a CMC reviewer, CMC Team Leader, acting Deputy Division Director, and acting Division Director in the Office of New Drug Chemistry in the Center for Drug Evaluation and Research (CDER), and in the Center for Biologics Evaluation and Research (CBER).

Education

• MBA, Finance, University of Maryland
• Ph.D., Organic Chemistry, University of Maryland
• B.S., Biochemistry, University of Pennsylvania