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