Risk 4.0
The regulator cross-references everything.
FDA's AI acts on 40+ unified data sources, from dossiers and audit logs to longer traceability chains.
Contact Us
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Email: info@igenticai.com
GEN Dx Platform · Agentic Governance OS
Governance that acts before actions happen.
The governance execution layer for Pharma, Biotech and MedTech — and the infrastructure RegTech platforms build on top of. Enforce compliance at authoring, before the regulator's AI ever sees it.
97%First-time submission success
182+Enterprise systems connected
−20%Late-stage rework
24/7Continuous governance
Context
The regulator has upgraded.
Field Inspections
Every investigator carries AI.
ELSA is now in the hands of field staff. SOPs and CAPAs need to be audit-ready in real time, not next quarter.
Late Validation
Your teams write. ELSA doesn't wait.
Validating documents after they're written is the old model. Governance has to live at the authoring layer.
Platform
Govern before it happens.
01
Ingest
FDA, EMA, MHRA, PVDEA — continuously.
02
Map
SOPs mapped to every framework.
03
Govern
Every action governed pre-execution.
04
Detect
Cross-document drift surfaces instantly.
Programs
Three ways to work with us.
Whether you're deploying GENIE for your own submissions, delivering it to clients, or building on top of the governance layer — there's a path designed for you.
01 For Customers
Enterprise Program
For Pharma, Biotech and MedTech organizations deploying governance directly into their stack.
- Pre-built connectors: Veeva, SharePoint, CMX, eTMF
- Policy library: FDA, EMA, MHRA, PVDEA, SFDA
- Agent Passport™ for every governed workflow
- In-house AI team: former FDA reviewers on call
- 24/7 enterprise support & SLA
02 For Partners
Partner Program
For CROs, CDMOs, consultancies and SI partners delivering compliant AI to regulated clients.
- Co-deployment into client environments
- Implementation & advisory enablement
- White-glove onboarding for your accounts
- Revenue sharing & co-marketing
- Joint go-to-market across therapeutic areas
03 For Builders
Platform & API
The AI step for RegTech is healthspan. Embed GENIE governance into your own product with a few lines of code.
- REST + streaming APIs, SDKs in TS & Python
- Embedding engine & sentence-level traceability
- Agent Passport™ identity for every action
- LLM-agnostic — bring your own model
- On-prem, hybrid, or SaaS deployment
Comparison
Not a dashboard. An enforcement
layer.
| Capability | Other Tools | GENIE |
|---|---|---|
| Timing | After the fact | Pre-action enforcement |
| Mechanism | Monitor & alert | Intervene & remediate |
| Output | Dashboards | Audit-ready evidence |
| Scope | Single documents | Cross-document & system |
| Traceability | Report-level | Sentence-level |
| Deployment | External SaaS | Inside your environment |
| AI support | LLM lock-in | LLM-agnostic |
Voices
What leaders are saying.
“GENIE introduces a level of trust and control that is critical for deploying AI safely in healthcare. With i-GENTIC, compliance is no longer reactive — it becomes part of the execution layer.”
Richard D. Daniels
Former global senior pharma leader
“The shift from static compliance to real-time governance is inevitable. Enterprises need solutions that move beyond monitoring and reporting, toward continuous enforcement.”
Prince Nair Murthica
Partner, Real Service
“Traditional systems act like checklists. They cannot tell you whether the data supports the answer or action being taken.”
Dr Ken Washington
Chairman, i-GENTIC AI
“GENIE transforms compliance from a backend task into a strategic, continuous process — embedding governance directly into the workflows that matter.”
Scott Howell
Former Chief Marketing Officer
“Speed to clearance is a major competitive advantage. Governance AI reduces cycle time and raises confidence for the rigor of FDA scrutiny.”
Scott Van Valkenburgh
Board Member, i-GENTIC AI
“GENIE enables innovation without compromising oversight — exactly what healthcare needs right now.”
Dr Jean-Pierre Issa
Research leader
Foundation
Expert-trained. Expert-validated.
Trained on curated, domain-specific corpora — never the open internet. Benchmarked against real submission outcomes and inspection findings, with former FDA reviewers in the loop.
FDA, EMA, MHRA, IVDA, SFDA guidance
ICH E6, E8, E14, E19 standards
eCTD, IND, BLA, 510K, EU MDR
CAPA, Pharmacovigilance & CAPA precedent
The FDA's AI is live.
Is your governance?
See GENIE enforce compliance across a live submission workflow in under 30 minutes — or get the API keys to build on top of it.