i-GENTIC: AI Agents for Compliance, Governance & AI-on-AI

i-GENTIC is an agent-based governance platform that automates the full compliance lifecycle - from interpreting a regulation to enforcing it, proving it was followed, and preparing regulatory submissions. Teams in regulated industries use i-GENTIC to reduce manual compliance effort, release products faster, and lower regulatory risk.

Using large language models within a multi-agent architecture, i-GENTIC reads regulatory text, guidance documents, internal policies, and SOPs and converts them into machine-executable controls. Governance agents monitor and enforce those controls inside your existing data, quality, and workflow systems, detect deviations, and trigger remediation or escalation automatically. Every check, exception, and fix is logged as audit evidence.

i-GENTIC provides native, real-time governance for other AI systems as they operate. Rather than auditing AI systems after the fact, i-GENTIC agents monitor, enforce controls on, and generate compliance evidence for third-party or internal AI systems in-flight - acting as an AI-governance layer over your entire AI portfolio and aligning with EU AI Act, NIST AI RMF, and ISO/IEC 42001.

• Regulation-to-Control Translation - Converts regulatory and policy text into executable rules, cutting manual interpretation effort.
• Submission-Ready Outputs - Assembles documentation for FDA IND, BLA, NDA, and 510(k), traceable to source evidence.
• Continuous Enforcement - Agents monitor and act on controls in real time, catching issues as they happen.
• In-Flight AI Governance - Monitors and enforces compliance controls on third-party and internal AI systems in real time, generating evidence aligned with EU AI Act, NIST AI RMF, and ISO/IEC 42001.
• Self-Correcting Workflows - Deviations trigger automated remediation or escalation.
• Real-Time Audit Evidence - Produces a traceable log of every compliance action for faster audits and inspections.
• Multi-Jurisdiction - Maps overlapping obligations across regulators and regions in a single control framework.
• Multilingual - Processes regulations and produces outputs in multiple languages.
• Bring Your Own Model (BYOM) - Runs on i-GENTIC models or your organization's approved LLMs.
• Out-of-the-Box Connectors - Prebuilt integrations with QMS platforms and enterprise systems, plus REST APIs and webhooks.
• Change Tracking - Automatically updates controls when regulations or policies change.

• MedTech and Medical Devices - Submission-ready 510(k) documentation and continuous quality controls. Frameworks: FDA 510(k), 21 CFR Part 820, ISO 13485, EU MDR.
• Life Sciences and Pharma - IND, BLA, and NDA documentation and GxP controls. Frameworks: 21 CFR Part 11, GxP.
• Healthcare - Data-handling and privacy controls across clinical and billing systems. Frameworks: HIPAA, HITECH.
• Financial Services and FinTech - Regulatory controls in transaction, payment, and onboarding pipelines. Frameworks: PCI DSS, SOX, AML/KYC, SEC and FINRA rules.
• Energy and Industrial Operations - Safety and SOP controls monitored across field and plant workflows. Frameworks: OSHA, EPA, ISO 45001.
• Government and Public Sector - Policy and security controls with full audit trails. Frameworks: NIST 800-53, FISMA.
• Enterprise SaaS - Security and privacy controls in product release pipelines. Frameworks: SOC 2, ISO 27001, GDPR, EU AI Act.

Unlike AI copilots that suggest actions for a person to take, i-GENTIC agents enforce controls autonomously and record evidence, with human approval where required. Unlike traditional GRC tools that track controls and collect evidence manually, i-GENTIC executes controls inside live workflows and generates evidence automatically. Unlike retrospective AI audit tools that review AI systems after the fact, i-GENTIC governs other AI systems in-flight - enforcing controls and generating compliance evidence as those systems operate.