The path to FDA approval is stalled by manual oversight and fragmented documentation. The AI RegCheck Agent automates the grueling task of document-to-regulation mapping. By combining real-time regulatory intelligence with a "human-in-the-loop" interface, we help regulatory teams catch critical gaps weeks before the filing deadline.

Key Benefits

• Live Regulatory Alignment: Unlike static templates, our AI pulls from live FDA databases to ensure your checklist reflects current guidance.

• Instant Source Traceability: Every finding includes a direct link to the specific page and paragraph in your source files. No "black box" logic.

• Audit-Ready Workflows: Every AI suggestion is reviewable and overridable. All changes are logged for a complete audit trail.

• Holistic Package Review: Scan your entire submission folder simultaneously to identify inconsistencies across clinical and technical modules.

What You’ll See in the Demo

• Automated Checklist Generation: Building a submission-specific requirements list in minutes.

• The Gap Analysis Engine: Uploading document sets and receiving a prioritized list of missing or non-compliant elements.

• Evidence Mapping: A walkthrough of the "Click-to-Source" feature for rapid verification.

• Human Oversight Interface: How RA professionals validate or dismiss AI findings to maintain control.

Key Takeaways

• How to shift from manual document checking to strategic regulatory review.

• Methods for identifying "hidden" gaps that lead to Refuse-to-Accept (RTA) decisions.

• Techniques for maintaining 100% data integrity in AI-assisted workflows.