What is a Dossier in Regulatory Affairs

What is a dossier in Regulatory Affairs? Learn about the Common Technical Document (CTD) and all 5 Modules contained within.

Common Technical Document - Wikipedia

What is a Dossier in Regulatory Affairs

PPT - “Development of a Harmonized Dossier for use Across Latin America” PowerPoint Presentation - ID:82736

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PDF) PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION

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A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

Frontiers Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region

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Dossier Preparation/ CTD (Common Technical Document)