Gulf Co-operation Council – GCC eCTD
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 Canada as per CA Module 1 specification version 2.2 |
| 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