eCTD publishing & submission

KnowledgeNet : eCTD Software to compile your eCTD dossiers effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.

Knowledgenet is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd ICH module 2-5 v3.2.2 & module 1 specifications of EU v3.0.3, US FDA (v2.01 and v2.3), GCC v1.2 and v1.5, South Africa (ZA-MCC) v2.1, Canada v2.2, Swissmedic (CH) v1.5, Thailand (Thai-FDA) v1.0, AU v3.1, Jordan v1.1 and similar regulatory authorities and NeeS specifications EU v4.0, GCC v1.2 and v1.5, AU v2.0

KnowledgeNET keeps you just a click away from achieving regulatory compliance and cross all boundaries in the cumbersome submission process. KnowledgeNET serves multiple users connected parallel in a user-friendly environment providing an interface between the industry and agency for transfer of regulatory information while at the same time taking into consideration the facilitation of creation, review, above all, the life cycle management and archiving of the electronic submission, and also maintaining an audit trail as per the 21 CFR Part 11 compliance.

KnowledgeNET in itself is a complete package that provides creating, organizing, sharing, archiving and managing complete dossiers with minimum efforts.

EU EMA

US FDA

ZM-MCC

CA-HCSC

GCC

CH

TGA

Thai-FDA

JO-FDA

KnowledgeNET Processing

KnowledgeNET Expertise in:

  • Collaborative submissions preparation and review
  • eCTD Submission Tracking
  • Auto correct PDF properties like inherit zoom, fast web access, PDF versions etc.
  • Health Authority query management
  • Flexibility to integrate with leading eDMS
  • End-to-end submission tracking
  • Compliant global eCTD templates
  • 21 CFR part 11 compliant
KnowledgeNET, eCTD software can easily save a company thousands of dollars by effectively utilising the eCTD software features.
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