The Electronic Common Technical Document system provides the standard, mandated format for regulatory submissions to the FDA. eCTD allows regulatory users to prepare and maintain the life cycle of regulatory submissions originating from Office of the Surgeon General/Army and DHA sponsored investigational product development.
eCTD supports two main functions: publishing and reviewing. While publishing creates the submission packages, the review process allows regulatory users to review those 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 savings
- Integration 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.