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Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
    Quality regulations
  8. Export & Import
  9. Pricing & Reimburcement
  10. Marketing
  11. Postmarketing
  12. Reevaluation & Reexamination
Medical Devices
Japan Monitor (ISSN 1550-3429)
Information Meetings
Legislation and Agreements
All in Japan (ISSN 1550-3402)
E-health Japan (ISSN 1550-3410)
EU Pharma & Medical Devices
Free documents

Japan Master Files (Enterprise-wide Use License)

Japan Master Files (Enterprise-wide Use License)Quantity in Basket:none
Code: 7_D_M002

82-page document. This is a JKS Milestone document - describing a Manufacturing phase of the lifecycle of the regulated medicinal products in Japan. Full up-to-date description of the basics of the Master File system as implemented in Japan with complete references and annotations. Copyright JKS LLC 2006.