Ennov InSight Publisher eCTD 4.0

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

— eCTD 4.0 includes a new structure that enables the use of a single format for ICH, Japanese, and US specifications.

— With eCTD 4.0, the maintenance is simplified and regulatory changes for compliance are addressed without delay.

— 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.

Ennov InSight Publisher 7.3: eCTD 4.0

eCTD 4.0 Templates