TH eCTD Compiler

TH eCTD Compiler - FDA Thailand eCTD Publishing

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

eCTD Office produces valid Food and Drug Administration eCTD electronic submissions.

Fully compliant with TH eCTD specification Module 1 regional information, version 1.0 and Thai FDA eCTD Validation Criteria, version 1.0/01.

TH eCTD Compiler in Action!

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

By using the TH eCTD Compiler and its change control process, several topics including regional-aware approved module 1 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 Thai FDA / ICH eCTD specification.