South africa (ZA-MCC) eCTD
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