The contractor will provide Think Trends Software as an agentic AI and document intelligence solution for end-to-end processing of FDA adverse event documents, including scanned PDFs, forms, narratives, attachments, medical records, complaints, lab reports, and follow-ups. It must automate intake and classification, agentic OCR and structured data extraction, Center-specific processing for CVM, CDRH, CTP, HFP, CDER, and CBER, validation and quality control with human-in-the-loop review, data standardization and regulatory output generation, workflow triage, and AI-enabled FOIA redaction. Key differentiators include agentic OCR, a Center-agnostic core with Center-specific configuration, source traceability, confidence-based routing, multi-format processing, duplicate and follow-up detection, and reviewer-ready case summaries. The solution must deploy in secure FDA-aligned government cloud or FDA-managed/approved hosting environments with role-based access, audit logs, encryption, and enterprise identity integration. Expected outcomes include reduced manual processing, faster intake and triage, improved data quality and consistency, enhanced auditability, better backlog and surge handling, and a scalable foundation for future FDA adverse event modernization.