FDA Compliance & Regulatory Consultant, Blue Bell Consulting
MBA, Marketing, University of North Carolina, Chapel Hill, USA
PhD, Michigan State University, Michigan, US
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.
Blue Bell Consulting has been providing professional services for 16 years to pharmaceutical and medical device 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 and medical device companies, suppliers and contract manufacturers in the region and worldwide. He also helps API and dosage form pharmaceutical companies as well 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 and medical device companies as well.