CA eCTD Compiler

CA eCTD Compiler - HCSC (Health Canada) eCTD Publishing

CA eCTD Compiler, a part of eCTD Office, is an eCTD validation, creation, manipulation, viewing and publishing software solution for HCSC electronic submissions for human medicinal products.

eCTD Office produces valid Health Canada eCTD electronic submissions.

Fully compliant with Guidance to Industry: Preparation of Drug Submissions in the eCTD Format Module 1 Specification, version 2.2 and HCSC eCTD Validation Criteria, version 2.2.

CA eCTD Compiler in Action!

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

By using the CA 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 HCSC / ICH eCTD specification.