*Structured Review KASA New Contract

OPQ's Knowledge-Aided Assessment and Structure Application (KASA) is a tool developed for the reviews focused on making the application review more structured and efficient. Assessment templates are pre-populated with data, algorithms for risk identifications, mitigation and communications all in a structure format, while minimizing the text-based narratives, administrative task and summaries of information. KASA enhancements plan new features to support NDA and BLA quality structured review assessments and to facilitate integration with OneNexus and AI-assisted review. - OneNexus Platform Integration: Integrate KASA with OneNexus for Facilities, DMF, and all marketing applications to create a unified regulatory ecosystem. - AI Workstream/Intelligent Review Automation: Integrate FDA AI tools (including Elsa, Google Gemini, etc.) building workflows enabling auto-populating AI responses within the structured review system, reducing manual data entry and improving review efficiency for ANDA, NDA, DMF, Facilities, etc. - Quality Assessment Module Development: Leverage current ANDA modules to create comprehensive NDA quality assessment modules covering drug products, manufacturing processes, facilities, microbiology, and biopharmaceutics. - Deficiency Management and Communication: Automate compilation and communication of KASA assessment deficiencies through OneNexus. - Advanced Data Visualization and Communication: Implement visualizations for scientific data within OneNexus with drill-down capabilities and coordinated communication to industry stakeholders. - Comprehensive Reporting and Analytics Capabilities: Develop intuitive end-user reports and analytics views within the application.