eCTD Viewer | Link Documents Directly to Your DMS

Work together to speed up submissions times

Kivo makes it easy to find, share and submit response information

Agency submissions and responses require efficient cross-team collaboration - and rely on accurate, controlled information. Kivo’s eCTD viewer makes it easy for your entire team to find, share and view that key information - and for your submissions team to manage their work together.

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eCTD Viewing

Link Documents Directly to the DMS

Because Kivo’s eCTD viewer leverages our intuitive DMS, every document or correspondence is instantly accessible - with all its associated metadata and audit trail. it’s also easy to see which documents - and versions - were included and referenced in every submission or response.

Benefits of Kivo eCTD Viewer

Easily Grant and Manage Access

Easily grant or revoke access for everyone on your team, including view-only access for everyone in your organization, so you are all on the same page.

No Installation Required

Our viewer is fully browser based, compatible on Mac or PC, and requires no local install to run.

Module & Sequence Views

Our flexible viewer allows you easily navigate modules and switch between individual sequences, current, or cumulative views

Linked Directly to DMS

Live document links make all associate metadata and audit trails instantly accessible. The original document is one click away at all times.

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See how Kivo can help your team reduce manual work and improve compliance.

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An eCTD, or electronic Common Technical Document, is a standard format for the submission of regulatory information to health authorities, primarily for pharmaceuticals and biopharmaceuticals. It streamlines the submission process by allowing companies to submit their applications, including new drug applications and variations, in a consistent electronic format. eCTD Version 4.0 is the latest format, and is in use by FDA CBER and CDER as of September 16, 2024. To learn more about eCTD 4.0, visit this article.

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.

The eCTD format is accepted by several countries and regions include the United States (FDA), the European Union (EMA), Japan (PDMA), Canada (Health Canada), Switzerland (Swissmedic), Australia (TGA), Singapore (HSA), South Korea (MFDS). Additional countries are in the process of adopting eCTD or have established guidelines for its use. The trend is increasingly towards the acceptance and requirement of eCTD format for regulatory submissions globally.

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KIVO ECTD VIEWER

Locate the right version, right away.

Work together to speed up submissions times

Kivo makes it easy to find, share and submit response information

eCTD Viewing

Link Documents Directly to the DMS

Benefits of Kivo eCTD Viewer

Easily Grant and Manage Access

No Installation Required

Module & Sequence Views

Linked Directly to DMS

Accelerate Your Workflow with Kivo

Kivo eCTD FAQs

Accelerate Your
Workflow with Kivo