i-GENTIC: Autonomous AI Agents for Compliance & Governance

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 standard operating procedures and converts them into machine-executable controls. Governance agents then 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. For MedTech and Life Sciences teams, i-GENTIC assembles submission-ready documentation for FDA pathways including IND, BLA, NDA, and 510(k). Financial services teams use it to maintain continuous PCI DSS and related controls. Your organization stays audit-ready continuously instead of reconstructing proof after the fact.

i-GENTIC operates in four stages:

• Ingest - Upload or connect regulatory texts, guidance documents, internal policies, contracts, and SOPs to the platform.
• Translate - LLM agents interpret each obligation and convert it into a machine-executable control, mapped back to its source clause.
• Enforce - A swarm of governance agents monitors data, quality, and workflow systems continuously, blocks or flags violations, and triggers remediation or human escalation.
• Evidence - Every check, exception, and remediation is logged with timestamps and source references, producing audit-ready reports and submission-ready documentation on demand.

• Regulation-to-Control Translation - Converts regulatory and policy text into executable rules, cutting manual interpretation and control-design effort.
• Submission-Ready Outputs - Assembles documentation for regulatory submissions such as FDA IND, BLA, NDA, and 510(k), traceable to source evidence for review and approval by your regulatory team.
• Continuous Enforcement - Agents monitor and act on controls in real time, catching issues as they happen rather than at audit time.
• Self-Correcting Workflows - Deviations trigger automated remediation or escalation, reducing exposure and manual follow-up.
• Real-Time Audit Evidence - Produces a traceable log of every compliance action for faster, lower-effort audits and inspections.
• Multi-Jurisdiction - Maps overlapping obligations across regulators and regions in a single control framework for global operations.
• Multilingual - Processes regulations and produces outputs in multiple languages, supporting global teams and non-English regulators.
• Bring Your Own Model (BYOM) - Runs on i-GENTIC models or your organization's approved LLMs to meet internal AI policies and model governance rules.
• Out-of-the-Box Connectors - Prebuilt integrations with QMS platforms and common enterprise systems, plus REST APIs and webhooks for custom integrations.
• Change Tracking - Automatically updates controls when regulations or policies change, keeping compliance current with less rework.

• MedTech and Medical Devices - Prepare submission-ready 510(k) documentation and keep design and quality controls continuously compliant. Frameworks: FDA 510(k), 21 CFR Part 820, ISO 13485, EU MDR.
• Life Sciences and Pharma - Assemble submission-ready IND, BLA, and NDA documentation and enforce GxP controls across quality systems. Frameworks: FDA IND, BLA, NDA, 21 CFR Part 11, GxP.
• Healthcare - Enforce data-handling and privacy controls across clinical and billing systems. Frameworks: HIPAA, HITECH.
• Financial Services and FinTech - Enforce regulatory and internal controls in transaction, payment, reporting, and onboarding pipelines. Frameworks: PCI DSS, SOX, AML/KYC, SEC and FINRA rules.
• Energy and Industrial Operations - Turn safety and operating SOPs into controls monitored across field and plant workflows. Frameworks: OSHA, EPA rules, API standards, ISO 45001.
• Government and Public Sector - Apply policy and security controls to programs and data systems with full audit trails. Frameworks: NIST 800-53, FISMA.
• Enterprise SaaS - Embed 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