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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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4. Dossier




Q&A related to the Electronic CTD Specification (Single User License)Q&A related to the Electronic CTD Specification (Single User License)
Code:4_D_K001
Price: $115.00
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Q&A related to the Electronic CTD Specification (Enterprise-wide Use License)Q&A related to the Electronic CTD Specification (Enterprise-wide Use License)
Code:4_D_K002
Price: $460.00
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Specific Q & A On CTD - Quality Guideline for Japanese Submission (Single User License)Specific Q & A On CTD - Quality Guideline for Japanese Submission (Single User License)
Code:4_D_K003
Price: $125.00
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Specific Q & A On CTD - Quality Guideline for Japanese Submission (Enterprise-wide Use License)Specific Q & A On CTD - Quality Guideline for Japanese Submission (Enterprise-wide Use License)
Code:4_D_K004
Price: $500.00
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Japanese CTD/eCTD Basics (Single User License)Japanese CTD/eCTD Basics (Single User License)
Code:4_D_M001
Price: $875.00
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Japanese CTD/eCTD Basics (Enterprise-wide Use License)Japanese CTD/eCTD Basics (Enterprise-wide Use License)
Code:4_D_M002
Price: $3,750.00
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Package Insert MobicPackage Insert Mobic
Code:6_D_K001
Price: $150.00
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Japanese Pharmaceutical Affairs Authorities Regulatory Documents - May 2003 Full ListJapanese Pharmaceutical Affairs Authorities Regulatory Documents - May 2003 Full List
Code:JM_N_001
Price: $50.00
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Japanese Pharmaceutical Affairs Authorities Regulatory Documents - June 2003 Full ListJapanese Pharmaceutical Affairs Authorities Regulatory Documents - June 2003 Full List
Code:JM_N_002
Price: $50.00
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