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 Pre-defined 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|