DOSSIER/DMF COMPILATION
U.S.A/Canada/Europe Emerging Markets Clinical/Non-Clinical Overview

DOSSIER/DMF COMPILATION SERVICES

Docent Pharma services have handled many regulatory submissions, in different countries, on behalf of client companies.

Docent Pharma Regulatory Consultant assists Life Science Clients with the following services:

  • Compilation/Preparation of Dossier in CTD [Common Technical Document] Format [Module 1 – Regional, Module 2 to Module 5]
  • Compilation/Preparation of DMF [Drug Master File]
  • Compilation/Preparation of Dossier in ACTD [Asean Common Technical Dossier] Format
  • Amendment, Supplement, Annual Report, Annual Updates & Variation Application Compilation for Regulated & Emerging Market
  • Dossier/DMF Review & Gap Analysis
  • Clinical/Non-Clinical Overview
  • Responses for MOH/Authority Queries

Docent Pharma Can Assist :

Regulated Market Submission

  • U.S.A
  • Canada
  • Europe

Emerging Market Submission

  • Asian Countries
  • Southeast Asia Countries
  • CIS Countries
  • African Countries
  • Latin America
  • GCC Countries