Ontology-Powered Β· Multi-Jurisdiction Β· Updated Daily

Regulatory Data,Decoded by Ontology.

Not just collecting regulatory data β€”
structuring it with GxP ontology for scientific interpretation.

Data SourcesFDAMFDSICH

174K+

510(k)

28K+

Drug Approvals

3,900+

Warning Letters

2,400+

FDA Guidances

How We Structure Regulatory Knowledge

The process of transforming regulatory data into actionable intelligence

Step 1

Real-Time Collection

Automatically collect FDA, MFDS, and ICH regulatory data daily with incremental change detection.

FDA21 CFRMFDSICHOpenFDAOrange Book
Step 2

Ontology Structuring

Extract regulatory entities and connect them through a GxP ontology-based semantic structure.

GxP OntologyEntity ExtractionSemantic LinkCross-Reference
Step 3

Intelligence Delivery

Deliver structured knowledge as regulatory insights, AI analysis, and compliance tools.

InsightsAI ChatSimulator

From Raw Data to Regulatory Decision

Regulatory data transformed into actionable insights

Regulatory Intelligence, Delivered

AI-powered tools supporting every stage of regulatory work

AI Regulatory Chat

Get accurate, CFR-cited answers powered by ontology-based RAG.

  • FDA & MFDS integrated database search
  • Direct CFR citation support
  • Warning Letter risk analysis

Compliance Radar

Preview

Quickly detect regulatory gaps in your documents. Try now with a sample document.

  • Automated gap report detection (5 domains supported)
  • Automatic Warning Letter risk matching (similar 483/WL cross-ref)
  • Isolated enterprise deployment option available

Built for Regulatory Precision

Only systematically verified data is delivered

Real-Time Regulatory Updates

FDA, MFDS, and ICH official data is automatically collected. New guidances, warning letters, and recalls are reflected as soon as they are published.

AI-Organized Key Insights

Automatically extracts and organizes key information from hundreds of pages of regulatory documents β€” related products, violations, applicable standards, and more.

Regulatory Intelligence at a Glance

Search and analyze over 170,000 clearances, warning letters, and recall records, and identify industry trends.

See the connections in
regulatory data yourself

From ontology-powered regulatory insights to real-time enforcement analysis β€” start for free.

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