Healthcare Regulatory Compliance, Automated.
DENI is an AI-powered Compliance Operating System that helps healthcare companies prepare, validate, and maintain compliance with FDA-style regulators across countries.
What DENI Does
A structured approach to healthcare regulatory compliance, powered by AI that you can trust and audit.
Ingest Regulatory Guidance
Connect regulatory requirements and internal documentation into a unified system.
Build Compliance Graph
Create a structured graph linking rules, evidence, and data across your regulatory landscape.
Produce Regulator-Ready Outputs
Generate submission packages with full traceability and reviewer-ready documentation.
How It Works
From ingestion to submission-ready outputs, DENI provides a clear, auditable workflow.
Connect Sources
Link regulatory guidance documents and internal documentation to DENI. The system ingests and indexes your compliance materials.
Build Compliance Graph
DENI constructs a structured graph connecting regulatory requirements to evidence, identifying gaps and relationships.
AI Agents Validate
Autonomous agents reconcile requirements against evidence, flag inconsistencies, and validate compliance posture.
Generate Outputs
Produce submission-ready packages with clear reasoning, traceable evidence, and reviewer-ready documentation.
Why Now
The regulatory landscape demands a new approach to compliance.
Growing Regulatory Complexity
Healthcare regulations are expanding across geographies. Manual processes cannot keep pace with evolving requirements.
Manual Workflows Don't Scale
Traditional compliance relies on human reviewers. This creates bottlenecks and increases the risk of missed requirements.
AI Must Be Explainable
Regulatory contexts demand traceability. AI is only viable when every decision can be audited and defended.
Prepare your next regulatory submission with confidence
See how DENI can help your team stay audit-ready and accelerate compliance workflows.