Ensure access to the Chinese market
Preparing, Participating and Handling a Chinese Food & Drug Administration (CFDA) Inspection
Presented by Dr. Mel Dong (Blue Bell Consulting)

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Based in Shanghai, China, Blue Bell Consulting has been providing GMP Consulting, auditing and training services since 2003 for FDA- and CFDA-regulated industries worldwide.

Clinical Supplies Consulting Services, a professional services firm specialized in providing management consulting services to the pharmaceutical industry in the area of investigational medicinal products (IMPs) and related topics within the entire pharmaceutical development process chain.


Genau & More provides a comprehensive range of compliance services for life sciences aimed to advance quality in patient care and safety. Specializing in project management, GAP analysis, validation and change management, Genau & More provides both senior experience as well as hands-on execution of projects based on accurate regulatory interpretations. Their services provide clients with a distinct competitive advantage based on long-term inspection readiness, fast time to market and significantly reduced costs.

KBJ Pharma specializes in assisting pharmaceutical companies in all issues concerning Quality Assurance. In particular they focus on Quality Assurance, Legislative matters, In-house training in GMP and Postgraduate training in GMP.

Key2Compliance® is an independent company providing knowledge and information about CGMP and Quality Systems to the health care industry. Key2Compliance® has an international network providing its training, consultancy and products to a variety of functions in the health care industry, from development to market in terms of Quality Systems and GMP compliance. They are also publishing GMP regulation booklets, handbooks, Play4GMP® learning games and other tools for compliance training.


Nishiyama Consulting Office offers GMP consultation and auditing services including on-site training to Pharmaceutical and API companies in Japan; especially those needing comprehensive support while undergoing FDA inspection.

The strategic business unit PharmLink Consultants has offered results-oriented and competency-based consulting services since 1989 in the sector of the processes of providing clinical trial, pharmaceutical development, GMP compliance, and all the related topics.