In Switzerland electronic submission is accepted in eCTD as well as CTD format, so KnowledgeNET, is fully compliant as CH eCTD Software with CH Module 1 Specification, version 1.5 and Validation Criteria version 1.5, will be required by Swissmedic Agency (CH).

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 ca hcsc ectd

CA-HCSC

 

gulf co operation council gcc ectd

GCC

 

Swissmedic (CH) eCTD Software Capabilities

CH eCTD Template System have Pre-defined eCTD Template of Switzerland region 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 of Switzerland as per CH Module 1 specification version 1.5
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

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