AU eCTD Compiler

AU eCTD Compiler - TGA eCTD Publishing

AU eCTD Compiler, a part of eCTD Office, is an authenticated eCTD preparation, validation, creation, manipulation, viewing and publishing software solution for TGA eCTD electronic submissions.

eCTD Office produces valid Therapeutic Goods Administration eCTD electronic submissions.

Fully compliant with AU eCTD specification Module 1 and regional information, version 3.0 and TGA eCTD Validation Criteria, version 3.0.

AU eCTD Compiler in Action!

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

By using the AU eCTD Compiler and its change control process, several topics including regional-aware approved template, lifecycle management, attributes, granularity, 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 TGA / ICH eCTD specification.