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Mel Dong , MD, PhD

W. Mel Dong
President, Blue Bell Consulting
Adjunct Professor, Fudan University School of Pharmacy

MBA, Marketing, University of North Carolina, Chapel Hill, USA
PhD, Pharmacology and Toxicology, Michigan State University, E. Lansing, MI, USA
MD, Shanghai First Medical College, Shanghai, China

Dr. Dong was a former regulatory reviewer at the U.S. Food and Drug Administration (FDA) responsible for premarket clearance of submissions by regulated industries as well as a member of FDA field inspection team. He has participated in numerous site inspections. He is also experienced in designing, conducting, analyzing, and reviewing preclinical experiments and clinical trials for premarket approval and postmarket surveillance. With nearly 20 years of experience in the U.S., Dr. Dong came back to China in 2004. He has developed a large client base in the Asian Pacific Region and served product development and OEM needs of both local and international companies. Currently, Dr. Dong is President of Blue Bell Consulting, a regulatory consulting firm located in Shanghai, China.
Professional services provided by Dr. Dong mainly include:

GMP/QSR/GLP/GCP compliance consultation, strategy and gap analyses
Pre-approval and other GMP regulatory audits and mock inspections
Third party monitor of GLP and GCP studies
Development of practical GxP training courses and workshops
Validation of facilities, equipment, and analytical methods
Development of SOP and other GxP documentation systems
Consultation meetings with both Chinese and U.S. FDAs
Preparation and review of regulatory documentations: DMFs, INDs, ANDAs, NDAs, BLAs, 510(K)s, PMAs, and annual reports

Regulatory courses instructed by Dr. Dong in English and Chinese currently include:

cGMPs: Interpretation and Application for Dosage Forms
cGMPs: Interpretation and Application for APIs
cGMPs: Validation and Qualification
cGMPs: Laboratory Controls
cGMPs: Batch Records Review and Investigations
cGMPs: GMP Compliance Auditing
cGMPs: GMP Compliance Auditing for Sterile Pharmaceuticals
FDA Regulations on New and Generic Drugs
FDA Regulations on APIs
FDA Regulations on GLP and Site Inspection
FDA Regulations on GCP and Site Inspection
FDA Regulations on Human Drugs (Fudan course)
Basic Principles and Applications of Pharmacoeconomics (Fudan Course)