ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD)
U.S.A/Canada/Europe U.S.FDA’s ESG Submission

ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SERVICES

eCTD submissions are increasingly recommended by International drug regulatory agencies such as U.S.FDA, EMA, Health Canada.

Docent Pharma offers the following eCTD services to Life Science Clients:

  • Document Development for eCTD Submissions readiness
  • Submissions Compilation & Assembly for Dossier(Module 1 – Regional, CTD Module 2 to Module 5)
  • Submissions Compilation & Assembly for DMF
  • Consultancy for Transition from Paper Based System to eCTD Format
  • U.S.FDA’s Electronic Submissions Gateway (ESG) Submission

Assist in USFDA eCTD Submission
Assist in Health Canada eCTD Submssion
Assist in European eCTD Submission

Docent Pharma’s Regulatory Consultant/Specialist assists you for eCTD creation and submission.