AI adoption in life sciences is accelerating — but governance is being outpaced. The organizations winning in 2026 are those who built the compliance foundation first. USDM is purpose-built to be that foundation.
60% of pharma organizations are running GenAI pilots. Fewer than 6% of enterprise data meets FAIR standards. Fewer than half have formal AI ethics councils. The gap between AI experimentation and compliant enterprise deployment is where companies get hurt — and where USDM operates.
FDA’s AI/ML Action Plan, EU AI Act (enforcement live now), ICH E6 R3, and GAMP 5 Second Edition are all converging on the same requirement: AI in regulated contexts must be validated, monitored, and documented. Companies without governance by mid-2026 will have no runway to remediate.
The companies scaling AI fastest aren’t the ones with the most pilots — they’re the ones who solved governance first. Organizations establishing AI governance infrastructure now will hold a 12–18 month competitive advantage when regulators begin enforcement actions against unprepared organizations in 2026–2027.
Structured diagnostic across six AI maturity dimensions — strategy, governance, data, talent, deployment, and ethics. Produces a calibrated maturity score, peer benchmarks, shadow AI inventory, and a prioritized 90-day roadmap specific to your regulatory context.
Build the compliance infrastructure your AI portfolio requires. USDM implements the TRUST-AI governance framework — policies, SOPs, risk classification, and governance committee structure — establishing the controls that allow compliant AI deployment at scale.
With governance rails in place, USDM supports scaled AI deployment — PoC development, GxP-validated production systems, ongoing model monitoring, and AI Governance as a Service to maintain compliance as your AI portfolio grows.
25+ years exclusively in life sciences. Our consultants speak FDA’s language — CSA, Part 11, GAMP 5, ICH — because they’ve operated in these environments for decades. We don’t explain regulations; we navigate them daily.
We don’t just govern AI — we build it. USDM’s AI CoE delivers validated PoCs, GxP-compliant LLM pipelines, and production-ready AI systems. ProcessX on ServiceNow. AI-assisted validation. LLM output testing. End-to-end.
Delivery PODs operating in both US and EU markets — providing real regulatory insight, not theoretical compliance advice. Follow-the-sun execution with local regulatory expertise in both jurisdictions simultaneously.
Most IT consultancies can’t speak to FDA inspectors. Most quality consultancies can’t fix the systems. Most AI firms don’t understand GxP. USDM does all three.
The AI Center of Excellence combines USDM’s 25-year regulated technology track record with a purpose-built AI practice — operating on a Build-Sell-Deliver model with dedicated US and EU delivery PODs.
Start with a structured AI Readiness Assessment — fixed-fee, executive-ready output.