In South Africa an eCTD submission is accepted as well as CTD Paper submission so KnowledgeNET is fully compliant with ZA (South Africa) Module 1 Specification, version 2.1 and Validation Criteria version 2.1, will be required by Medicines Control Council (MCC).
ZA-MCC eCTD Software Capabilities
|ZA-MCC eCTD Template||System have Pre-defined eCTD Template of South Africa (ZA-MCC) as per regulatory specification|
|Project Management||In one project, system can manage all related sequences from sequence 0000 to infinity|
|Envelop||System automatically generate the Envelop as per ZA-MCC eCTD Module 1 specification version 2.1|
|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|