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


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