Dr. Mel Dong
FDA Compliance & Regulatory Consultant, Blue Bell Consulting
MBA, Marketing, 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.
With over 25 years of experience in the U.S., Dr. Dong founded Blue Bell Consulting in Shanghai, China in 2003, dedicating his professional services 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. Requested by domestic and international pharmaceutical companies, Dr. Dong frequently audits pharmaceutical companies, suppliers and contract manufacturers in the region. He also helps API and dosage form pharmaceutical 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.