Quality Systems in Japan
Quality Management System (QMS) Audits
Foreign Manufacturing Accreditation (FMA)
Audits
Drug GMP Audits
Quality systems are a key issue in Japan's medical markets. Japanese quality requirements are often more stringent than in the West. With the new Pharmaceutical Affairs Law (PAL) in 2005, a number of new quality standards have been implemented in Japan. Many of these Japanese quality standards and regulations have different names and content from similar Western standards.
PBM's Japan quality experts can advise your company on ensuring that your Japanese operations comply with new quality standards. We also do QMS "mock audits" to prepare your facility for a PMDA inspection.
For more information on Japanese quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.
- Japan Medical Device Updates (webcast for sale)
- Japan Device Reimbursement (webcast for sale)
- Japan Quality Audits 2010 (publication for sale)
- Japan QMS Audits 2010 (webcast for sale)
- Foreign Manufacturer Accreditation for Drugs in Japan (webcast for sale)
- Updates on Japan's Expanding Medical Device Market (webcast for sale)
- Looking East for R&D and Clinical Trials
- Lost in Translation: The Challenges of a QMS Audit
- Japan Quality Audits 2010 (publication for sale)
- Japan QMS Audit for Medical Device Registration (webcast for sale)
- Doing Business in Japan (webcast for sale)
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