Mel Dong, MBA, PhD, MD
Managing Director, Blue Bell Consulting

MBA, University of North Carolina, Chapel Hill, USA
PhD, Michigan State University, Michigan, USA
MD, Shanghai First Medical College, Shanghai, China

Dr. Dong was a U.S. FDA veteran responsible for premarket clearance of submissions by regulated industries as well as a member of FDA inspection team and participated in numerous on-site inspections.

Dr. Dong has been providing professional services for 16 years to pharmaceutical manufacturers in Greater China, Asia Pacific Area, and around the world and helping clients to improve overall Good Manufacturing Practice (GMP) compliance level. Dr. Dong frequently audits pharmaceutical companies, suppliers and contract manufacturers in the region and worldwide. He also helps API and dosage form pharmaceutical, as well as medical device companies in handling of FDA inspections, citations, and regulatory actions. Representing clients, he coordinates and participates industry meetings at the FDA headquarter in U.S.

As a well-known expert in GMP compliance area, Dr. Dong provides consultation services to the China Food and Drug Administration (CFDA) and provincial CFDA in China on compliance and regulatory issues. Invited as instructor by the CFDA Training Center, Dr. Dong teaches bilingual cGMP training courses for CFDA and provincial CFDA inspectors in China, and of course, for pharmaceutical companies as well.

His portfolio client firms include pharmaceutical companies worldwide, particularly local Chinese pharmaceutical Chinese companies with API, solid dosage form, injectable, aseptic and medical device products that comply with or in the process of complying with the U.S. and/or E.U. GMPs.