Ennov InSight Publishing

Ennov InSight Publishing enables you to create a complete submission package.

— Use submissions wizards to streamline the initiation of submissions that comply with ICH, Japanese, EU, US, STF, GCC, Swiss, AU, TH, Canadian, JO, CN, EAEU, WHO, WAHO, UA, and TW specifications.

— Quickly create all the necessary components for a paper submission, compliant NeeS, or compliant eCTD submission, including the required ICH, STF, and regional XML files, the correctly named leaf files and folder structures, and any requisite navigation aids.

— Easily manage subsequent amendments, supplements and variations to your submissions using intuitive rightclick menu options and simple drag-and-drop features, making all updates in the context of the full application.

— Create multiple submissions in multiple regions using comprehensive, built-in templates.

— Automatically transform documents in multiple file formats into enhanced PDFs with bookmarks and hyperlinks.

— Move seamlessly from product registration management to submissions management to publishing your submission to tracking your data.

— Enhance the efficiency of your organization, reduce your time to market, and be assured of compliance with the latest regulatory guidelines and specification.