US eCTD Compiler

US eCTD Compiler - FDA eCTD Publishing

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

eCTD Office produces valid FDA eCTD electronic submissions.

Fully compliant with U.S. Module 1 Specification, version 1.3 (dtd 2.01) and 2.3 (dtd 3.3) and FDA eCTD Validation Criteria, version 2.2 and 3.1.

US eCTD Compiler in Action!

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

By using the US eCTD Compiler and its change control process, several topics including regional-aware approved template, visual STF builder, lifecycle management, attributes, granularity, and administrative 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 FDA / ICH eCTD specification.