Blue Bell Consultingú║Home > About BBC
About Blue Bell Consulting

Blue Bell Consulting is a premier consulting firm which provids professional services to pharmaceutical and medical device manufacturers all over the world. Professional services provided by BBC mainly include:

  • GMP/QSR compliance consultation
  • Gap analyses in accordance with 21 CFR Parts 210, 211, and/or 820
  • Mock FDA GMP/QSR inspections and audits
  • Practical GMP/QSR training courses, workshops, and seminars
  • Qualification of vendors, facilities, and equipment/instrument
  • Validation of manufacturing processes, analytical methods, and computer systems
  • Rebuttal to FDA 483s, untitled letters, and warning letters
  • Coordination of industry meetings with the U.S. FDA

Add: 9 Clearlake Drive, Centralia, IL 62801, USA
Email: bbc@bluebell-consulting.com

Managing Director

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.

Affiliates
PharmaNet, Inc.
GMP Compliance
John Y. Lee MBA, BA
   
LundĘŽn/Ellow ab and EuroGMP AB
GMP Compliance
   
Nishiyama Consulting Office
GMP Compliance
   
Cleanroom Management Associates, Inc.
Cleanroom Management
Anne Marie Dixon