EU eCTD Compiler

EU eCTD Compiler - European Union eCTD

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

eCTD Office produces valid European eCTD electronic submissions: national, centralised, MRP (mutual-recognition) or DCP (decentralised).

Fully compliant with EU Module 1 Specification, version 2.0 and EU eCTD Validation Criteria, version 5.0.

EU eCTD Compiler in Action!

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

By using the EU 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 EMEA / ICH eCTD specification.