GCC NeeS Compiler

GCC NeeS Compiler - SFDA Non-eCTD

GCC NeeS Compiler, a part of eCTD Office, is a NeeS creation, manipulation, validation and publishing system for SFDA electronic submissions for human medicinal products.

eCTD Office produces valid SFDA NeeS 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 NeeS Compiler in Action!

The main functionality of the GCC NeeS Compiler is the creation of valid SFDA electronic Non-eCTD dossier submissions products along with hyperlinked CTD-TOC and Module TOC generation.

Built in validation supporting regional rules ensures no invalid submissions can be generated.

Conforms to TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in GCC.

Regularly updated following the changes in the SFDA / ICH eCTD specification.