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|