KnowledgeNET is unique software for EU EMA eCTD submissions, which is fully compliant with EU Module 1 Specification, version 3.0.3 and Validation Criteria version 7.1. Software is ready with EU Module 1 Specification for all the european procedure, the version 3.0.3 entered into force in November 2017 for immediate use.

EU EMA eCTD submissions software capabilities

Tracking Table System generate “Common Tracking Table” required in MRP and DCP procedure
EU EMA eCTD Template System have Pre-defined eCTD Template of EU region as per regulatory specification
Submission Procedure Compatibility System fully support all submission procedure (MRP, DCP, Centralized and National Procedure) for eCTD and ASMF (Active Substance Master File), CEP, EDQM, Repository, etc. submission in EU region
Product Life cycle Management In one project, system can manage all related sequences from sequence 0000 to infinity. This is mandatory requirement for Life cycle management
Envelop System automatically generate the Envelop of RMS (Reference Member State) & involved CMS (Concern Member State) countries as per EU Module 1 specification version 3.0.3
Other dossier submission key features click here