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|