Mel Dong, MD, PhD, MBA

Dr. Dong, a veteran of the U.S. Food and Drug Administration (FDA), served in a multidisciplinary team responsible for premarket clearance of submissions by regulated industries and participated in numerous on-site compliance inspections as a member of FDA inspection team.

After his tenure at the U.S. FDA, Dr. Dong provides consulting, auditing, and training services since 2003 to pharmaceutical companies in Greater China, Asia Pacific Area, and around the world in establishing and strengthening his client companies’ Good Manufacturing Practice (GMP) quality systems, developing compliance strategies, and ensuring regulatory inspection readiness. Dr. Dong frequently audits pharmaceutical companies, suppliers, and contract manufacturers in the region and worldwide. He helps his pharmaceutical and biologics manufacture clients in handling of FDA/CFDA inspections, citations, and regulatory actions by developing, implementing, and communicating comprehensive corrective and preventive action plans. He also advises investment firms that are committed to bring innovative products to the market in evaluating the status of regulatory compliance of their target and existing portfolio companies during the performance of due diligence activities.

As a well-known expert in GMP compliance, Dr. Dong has been invited as instructor by the CFDA Training Center to teach bilingual cGMP training courses for CFDA and provincial CFDA inspectors in China. Many CFDA inspectors selected for its increasingly frequent overseas GMP inspections were trained by Dr. Dong in three separate week-long intensive GMP training courses in September and November of 2009.