Making of eCTD Dossier Preparation And Services

DocentPharma dossier can be used in Pharmaceutical Industries ideally for management of Dossier, Drug Master File, TAD and Product, create correspondence, manage departments documents for Legal, Human Resource, Accounts, RnD etc. The system can also be used to manage and validate the eCTD submissions.

eCTD (Electronic Common Technical Document) submissions are increasingly recommended by International drug regulatory agencies such as FDA, EMEA, Health Canada.

eCTD is a harmonized structure that facilitates reusable submission components across different global drug product submissions such as Abbreviated New Drug Application (ANDA) - US and Abbreviated New Drug Submission (ANDS) - Canada. Once an eCTD application is created for a specific drug and a specific regulatory agency (e.g., FDA), certain CTD modules can be reused for other regulatory agencies as well (Health Canada, etc.) with minimal to no changes.

DocentPharma offers the following eCTD services to ensure regulatory acceptable eCTD enabled submissions:

1. Preparation & Assist for Dossier assembly and compilation in eCTD Format (Module 1 - Regional, CTD Module 2 to Module 5)
2. Review & Validate eCTD Dossiers as per eCTD specification
3. Consultancy for Sample Submission/Pre-submission in eCTD Format
4. Consultation Services for Transition from Paper Based System to Electronic Common Technical Document (eCTD) System
5. Consultancy for navigation aid management including the table of contents, book marking and hyperlinks
6. Paper to electronic document conversion to provided searchable text based documents
7. Consultancy for Study Tagging Files (STF) for US FDA and Submission lifecycle management
8. Provides & Creates eCTD Templates for Module 1, Module 2 to Module 5 of US, Europe, Canada submission.
9. Electronic Submissions Gateway (ESG) setup and administration for electronic submissions