Archive and Clone for Other Regions

Turn your US submission into an EU submission or any other variation in a matter of minutes. It's easy to archive and clone submissions for country-specific guidance with seamless importing and automatic hyperlink management.

Archive into Documentum and Livelink
Simplify archiving and organize compiled submissions for storage seamlessly. DMS attributes are populated automatically with attribute mapping. You’ll gain insight as you view relationships between attributes quickly and efficiently.

Import and Clone for Other Regions
Turn a US submission into an EU submission in a few simple steps. With support for US, EU, CA, and JP regions, you can clone all or part of an application for other regions easily. Also clone link management hyperlinks and comments, and import previously created eCTDs from the database for other regions. You’ll experience a seamless transfer of links, submission formats and content from one submission to another.

Clone on a Modular Level
Cloning specific modules (2-5) of an eCTD, makes it easier to complete other submissions or create new submissions for various regulatory agencies. Whether it’s entire modules or only specific sections, you’ll save time while guaranteeing accuracy of information.