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CTD Dossier

CTD Dossier

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連絡先担当者 Sangam

Hodal, Haryana

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Description

CTD Format Dossiers


This Format of Dossier is an Important & widely used Dossier format in most of the country, This format of any registration application for Marketing Authorization Dossier is submitted to Food and Drug Authority or Ministry of health or any other equivalent authority along with other required documents.

SGPRC provide registration file for drug product registration in various countries all over the world for many Pharmaceutical Company in INDIA & for our International Business Associates.

SGPRC Provides Registration Dossier service in  Dossier Compilation, Dossier Preparation & Dossier Review in accordance to the respective Regulatory Authority Guidelines.

Pharmaceutical Dossier Compilation, Review and writing as per CTD Format

(Common technical Document)

 

Common Technical Document Consists of the following Modules with the number of the

required Documents.

Module 1 Administrative Information & Prescribing Information
Module 2 - Common Technical Documents Summaries
Module 3 Quality
Module 4 Non Clinical Study Report
Module 5 Clinical Study Report

CTD Format Dossier is widely used in semi regulated & regulated market like CIS Countries, Middle East countries, European Union, USA , Australia, African Countries, Canada, Japan, etc

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Sangam < SANGAM GLOBAL REGULATORY CONSULTANCY >

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