In Saudi Arabia submission is accepted in eCTD as well as NeeS format.KnowledgeNET, is fully compliant with GCC-Module 1 Specification (v1.2 and v1.5) and Validation Criteria (v1.2 and v1.4) , as required by Saudi Food and Drug Authority-SFDA. GCC eCTD Software : KnowledgeNet by Sarjen System is a comprehensive submission management system with Dossier life cycle management.

Key Features for GCC eCTD

GCC eCTD Template System have Pre-defined eCTD Template of GCC region as per regulatory specification
Project Management In one project, system can manage all related sequences from sequence 0000 to infinity
Envelop Generation System automatically generate the Envelop of Gulf Countries as per GCC Module 1 specification version 1.2 & version 1.5
Documents Transformation Transformation of source documents (MS Word) to pdf format through the system at time of publishing
Other dossier submission key features click here