KnowledgeNET

Sarjen's Global Dossier Publishing Software (often called KnowledgeNET) is a specialized regulatory compliance platform designed for the pharmaceutical and life sciences industries. Its core mission is to standardize and streamline the entire global regulatory submission process, leading to faster market approvals and improved compliance Core Functionality and AutomationThe platform simplifies one of the most complex tasks in the industry: the preparation, management, and submission of regulatory dossiers. It is built around automated workflows that are meticulously tailored to specific global regions, individual product lifecycles, and diverse regulatory authority requirements. This automation drastically reduces the manual complexity of dossier creation, validation, and submission.The solution ensures:Consistency: Maintaining a uniform process across all global submissions.Efficiency: Accelerating the overall time-to-submission.Accuracy: Minimizing human errors and compliance issues.Comprehensive Regulatory ScopThe software provides full support for major regulatory formats, including:eCTD (electronic Common Technical Document): The global standard for submission.CTD (Common Technical Document) and NeeS (Non-eCTD electronic Submissions).It handles a wide range of submission types, such as DMF (Drug Master Files), ASMF (Active Substance Master Files), ANDA (Abbreviated New Drug Applications), IND (Investigational New Drugs), NDA (New Drug Applications), BLA (Biologics License Applications), as well as post-marketing safety reports like PADERs and PSURs.The system also facilitates submissions for semi-regulated and non-regulated markets and supports other specific formats like SPL (Structured Product Labeling), NDC, and GDUFA drug listings.Key Features for Compliance and ManagemenThe platform incorporates several features crucial for efficient regulatory operations:Region-specific Dossier Management: Ensuring adherence to precise regulatory requirements, including those from the FDA and EU.Product-based Dossier Lifecycle: Managing all regulatory documentation for a product from its initial filing through all subsequent amendments and maintenance cycles.Automated Submission Workflow: Guaranteeing that the final submission package is correctly assembled and validated before dispatch.Regulatory Information Management System (RIMS) Integration: Providing a centralized hub for all regulatory data.Real-time Document Tracking and Version Control: Ensuring audit-readiness, maintaining data consistency, and simplifying the review and approval process.eCTD Viewer: Allowing stakeholders to easily review the dossier structure and content before final submission.Query & Life Cycle Management: Tools to effectively manage follow-up questions from health authorities and subsequent updates to the dossier.