CH eCTD Compiler

CH eCTD Compiler - Swissmedic eCTD

CH eCTD Compiler, a part of eCTD Office, is an eCTD validation, creation, manipulation, viewing and publishing system for Swissmedic electronic submissions for human medicinal products.

eCTD Office produces valid Swissmedic eCTD electronic submissions.

Fully compliant with Swiss Module 1 Specification, version 1.3 and Swissmedic eCTD Validation Criteria, version 1.3.

CH eCTD Compiler in Action!

The main functionality of the CH eCTD Compiler is the creation of valid Swissmedic electronic dossier submissions along with the lifecycle management.

By using the CH eCTD Compiler and its change control process, several topics including regional-aware approved template, lifecycle management, attributes, granularity, galenic forms and envelope values are addressed and solved.

Built in validation supporting regional rules ensures no invalid submissions can be generated.

Regularly updated following the changes in the Swissmedic / ICH eCTD specification.