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Medicinal Products Lifecycle
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Japan Monitor (ISSN 1550-3429)
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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

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_K001Q&A related to the Electronic CTD Specification (Single User License) $115.00
4_D_K003Specific Q & A On CTD - Quality Guideline for Japanese Submission (Single User License) $125.00
Type: Milestone document