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Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
  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
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Medicinal Products Lifecycle 4. Dossier

Japanese CTD/eCTD Basics (Single User License)

 
Japanese CTD/eCTD Basics (Single User License)Quantity in Basket:none
Code: 4_D_M001
Price:$875.00

 
 
 
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29-page document. This is a JKS milestone document - describing a Dossier phase of the lifecycle of the regulated medicinal products in Japan. Full up-to-date description of the basics of the CTD/eCTD as implemented in Japan with references and annotations. Copyright ゥ JKS LLC 2003.


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4_D_K001 Q&A related to the Electronic CTD Specification (Single User License) $115.00
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Type: Milestone document