KnowledgeNET

KnowledgeNET eCTD Publishing is a global dossier management and publishing platform developed by Sarjen Systems, designed for pharmaceutical and life sciences organisations that need to manage, compile, and submit regulatory dossiers across multiple regions and markets. The platform supports eCTD, CTD, and NeeS publishing formats and is built to address the complexity of multi-region, multi-product submission workflows.

The platform automates workflows tailored to specific regions, products, and regulatory authorities, with the stated goal of accelerating dossier creation, validation, and submission while reducing manual errors and compliance issues. Sarjen Systems reports that the platform has been used to produce over 5,000 dossiers and 4,500 SPLs, with coverage spanning more than 150 country structures, 140+ semi-regulated market submissions, and 120+ non-regulated market submissions.

Core Features

• Region-specific dossier management: supports submission structures tailored to the requirements of different regulatory authorities and geographic markets
• Product-based dossier lifecycle: organises and tracks dossiers according to individual product lines throughout their regulatory lifecycle
• Automated submission workflow: automates the steps involved in preparing and submitting dossiers, reducing manual intervention
• Regulatory compliance support: helps ensure submissions meet applicable regulatory standards
• Real-time document tracking: provides visibility into the status of documents within the submission process
• Version control: manages document versions to maintain accuracy and traceability
• Dossier review and approval: includes functionality to facilitate internal review and sign-off processes
• Audit-ready documentation: supports the maintenance of documentation in a state suitable for regulatory audits

Operational Benefits

• Standardises and streamlines the regulatory submission process across regions and products
• Reduces complexity associated with managing submissions for multiple regulatory authorities
• Improves data consistency across dossiers
• Aims to reduce time to regulatory approval by minimising compliance issues and manual errors
• Reported to improve return on investment and submission accuracy

Market Coverage

• Supports submissions across regulated, semi-regulated, and non-regulated markets
• Covers more than 150 country-specific dossier structures
• Applicable to eCTD, CTD, and NeeS submission formats

KnowledgeNET eCTD Publishing is part of Sarjen Systems' broader regulatory and compliance portfolio, which also includes a Regulatory Information Management System (RIMS) and an eCSV solution. Sarjen Systems additionally offers solutions across clinical research, pharmacovigilance, quality management, manufacturing, and supply chain domains.