Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD) system allows USAMRDC Office of Regulated Activities (ORA) users to prepare and maintain the life cycle of regulatory submissions originating from Office of the Surgeon General (OTSG)/Army sponsored investigational product development.
eCTD supports two main functions: publishing, which creates the submission packages and reviewing, which allows regulatory users to review the submission packages.
eCTD interfaces with EDMS to enable users to streamline the reviewing and publishing processes from project planning to submission archival. eCTD is FDA 21 CFR Part 11 compliant.
Features
- Electronic submission to the FDA gateway portal in accordance with FDA requirements.
- Centralized view of product details, document collection, and assimilation.
- Information is interlinked and can be cross-referenced within the submission.
- Amendments are fully integrated with previous and subsequent submissions, leading to a final single file application for the license of a new drug that is easy to navigate and review.
- Streamlines the review and publishing process.
- Eliminates reliance on outside vendor contracts for electronic submissions, providing a considerable cost saving to the Command.
- Integrate with EDMS to efficiently facilitate authoring of electronic submissions.
Training & Demos
A variety of training options and demos are available for eCTD.
If you would like to schedule a demo or training, or have any questions, please contact us.