Locate the right version, right away with eCTD Viewer.

Generally speaking. The eCTD (electronic Common Technical Document) format is not universally required, but it is increasingly becoming the standard for submitting regulatory documents to authorities in many regions, particularly for pharmaceuticals and biologics. The FDA and EMA require this format for all pharmaceutical submissions. It is also in use by Japan, Australia, Canada, South Africa, and Thailand as of Sept 2024. By using the eCTD format, you will likely speed up submissions in other regions. 

Kivo’s eCTD Viewer provides live links to the DMS, making all associated metadata and audit trails instantly accessible. This ensures teams can locate the original document and its history with a single click. 

Yes, Kivo’s eCTD Viewer allows administrators to easily grant or revoke access for team members, including view-only access, ensuring secure and collaborative workflows. Particularly for teams that are working with outsourced publishing partners, Kivo's eCTD viewer streamlines back and forth communication.