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 ca hcsc ectd

CA-HCSC

 

gulf co operation council gcc ectd

GCC

 

swissmedic ch ectd

CH

 

australia tga ectd

TGA

 

thailand thai fda ectd

Thai-FDA

 

jo fda

JO-FDA

 

eu ema ectd

EU EMA

 

us fda ectd

US FDA

 

south africa za mcc ectd

ZM-MCC

 

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

Book a Demo