Canada (CA-HCSC) eCTD
In Canada dossier submission is accepted in eCTD format as well as CTD Paper format so KnowledgeNET is fully compliant with Canada (CA-HCSC) Module 1 Specifications in both the formats, version 2.2 and Validation Criteria version 4.0, will be required by Health Canada (CA-HCSC). KnowledgeNET an eCTD software system have Pre-defined eCTD Template of Canada region as per regulatory specification for dossier publishing.
Canada eCTD Software Capabilities
| CA HCSC eCTD Template | System have Predefined eCTD Template of Canada 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