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 module 1 specifications 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) v1.4, Thailand (Thai-FDA) v1.0, AU v3.1, Jordan v1.0 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.

KnowledgeNET is a complete eCTD software for publishing and submission of dossier

KnowledgeNET is a complete eCTD software for publishing and submission of dossier

Region specific eCTD Dossier publishing & submission planning and life cycle management PDF auto correct Submissions & Publishing documents
  • Multi-region pre-defined template for submissions in a compliant manner with country specific requirements
  • Converting Non-eCTD electronic submission format (NeeS format) or paper format to eCTD format and vice versa
  • Document mapping between regional document submissions
  • Reminders for events attached to submissions
  • Using appropriate eCTD versions inclusive of accurate eCTD Modules, eCTD format, eCTD structure
  • PDF property manager: System internally manage the PDF properties like PDF Version 1.4 as per ICH specification
  • An excellent functionality of auto correction of standard PDF related properties required as ICH eCTD specification v3.2.2
  • Transformation from source document(MS Word) to eCTD specific document format, managing and processing source documents
  • Web based regulatory document management system for the source document management
  • DMF and ASMF publishing & submission for USFDA and EU
  • Generation of main table of content (TOC) for all modules (module 1 and Module 5) with hyperlinking
Dossier compilation Submit submissions Post submission query management
  • Cross-reference document Hyperlinking & tracking
  • Project metadata compilation/template management
  • Dossier lifecycle management
  • Submission history management
  • Tracking table generation
  • Validation of the project for submissions
  • Backbone XML validation
  • Checksum verification
  • Submission metadata verification with respect to country specific regulatory requirements
  • QM is a unique feature which helps in tracking creation, review and updates of submissions, amendments, Regulatory Agency’s query response along with its compilation and review. Thus, giving the company a quick response time to resolve warning letters or other issues. By QM, real-time alerts and notifications could be sent to appropriate users for further correspondence

KnowledgeNET, eCTD software can easily save a company thousands of dollars by effectively utilising the eCTD software features.

Other eCTD related software by Sarjen: Query Management (QM)

QM is a unique feature which helps in tracking creation, review and updates of submissions, amendments, Regulatory Agency’s query response along with its compilation and review.
Thus, giving the company a quick response time to resolve warning letters or other issues.
By QM, real-time alerts and notifications could be sent to appropriate users for further correspondence.