entimICE eCTD Generator


eCTD Generator is an off-the-shelf solution for creation and management of international eCTD submissions.

eCTD Generator speeds up submission creation by offering a region-specific submission structures compliant with ICH and regional schemas, including templates for the EU, US, CA and JP regions. The needed DTDs are automatically resolved and offered as setup settings. The tool controls the structure and allows inserting optional folders allowed by eCTD specification.


Your benefits

1. Submission templates for rapid setup

2. EU, US, CA and JP regional schemas

3. User-friendly interface

4. Linking to the single-source, central repository

5. Integrity through validation checks

6. Version checks for up-to-date information

7. Lifecycle management support

8. Generation of the XML backbone file

9. One-click generation of STF

What's new?

Entimo continuously develops and improves its products. Contact us for more information about Entimo's products, release information and roadmaps.

eCTD Generator Highlights

Easy dossier compilation

Adding files to the submission is made easy by drag-and-drop. To simplify reuse of information, source documents are uniquely stored in the central repository and are only linked to the submission folder during the submission setup phase.

Consistency and integrity checks

An integrated conformity checker ensures compliance of the XML to ICH and regional schemas. A built-in validation system checks for errors and outdated or missing files before submission creation. Maximum consistency is ensured by the version check tool integrated in the system. It checks for outdated or orphaned elements in the submission and automatically proposes to delete/update them. With eCTD Generator your submissions are always accurate and up-to-date.

Easy sequence creation

Create new sequence


Lifecycle management

A key feature of the tool is lifecycle management. New sequences are created as related or unrelated to earlier submissions. You can add,append or replace new elements, as well as exclude existing ones from the new sequence. All changes are reversible to restore the previous state.

Automated XML backbone generation

An XML backbone file is a primary technical component of an eCTD submission. eCTD Generator enables an effortless automatic creation of the XML backbone and Study Tagging Files in the background and stores the results in the defined location.

Full lifecycle management

Manage lifecycle