GCC eCTD Compiler

GCC eCTD Compiler - SFDA eCTD Publishing

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

eCTD Office produces valid SFDA eCTD electronic submissions for all Gulf countries, including: United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom Saudi Arabia and Republic of Yemen.

Fully compliant with Guidance for Registration and Gulf Cooperation Council Module 1 Specification, version 1.2 (/1.5) and SFDA eCTD Validation Criteria, version 1.2 (/1.4).

GCC eCTD Compiler in Action!

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

By using the GCC 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 SFDA / ICH eCTD specification.