ZA eCTD Compiler

ZA eCTD Compiler - SAHPRA eCTD Publishing

ZA eCTD (/eSubmission) Compiler, a part of eCTD Office, is an eCTD validation, creation, manipulation, viewing and publishing software solution for SAHPRA electronic submissions.

eCTD Office produces valid South African Health Products Regulatory Authority eCTD electronic submissions.

Fully compliant with Guidance for the submission of regulatory information in eCTD format Module 1 Specification.

ZA eCTD Compiler in Action!

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

By using the ZA 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 SAHPRA / ICH eCTD specification.