About USDM
25 years at the intersection of technology and regulated life sciences.
USDM is a life sciences technology and compliance consultancy. We help pharmaceutical, biotech, medical device, and CRO organizations govern AI, modernize systems, and maintain inspection-ready operations — inside GxP guardrails.
Regulated expertise, not generic IT
USDM consultants operate inside GxP environments every day. They speak FDA language — CSA, Part 11, GAMP 5, ICH — and understand what defensible compliance actually requires.
Build and govern AI together
Most firms can do one or the other. USDM governs AI and builds it: validated PoCs, GxP-compliant LLM pipelines, production AI systems, and the frameworks that make them defensible.
Follow-the-sun delivery
US and EU delivery PODs provide real regulatory insight and execution across jurisdictions where AI scrutiny is rising fastest.
Life sciences specialists
Our consultants have deep domain experience across pharma, biotech, CRO, and medical device — not generalist IT backgrounds.
US and EU presence
Delivery teams in both US and EU markets provide regulatory depth and follow-the-sun execution where AI scrutiny is rising.
TRUST-AI Framework
Purpose-built AI practice with a proprietary framework spanning governance, validation, implementation, and managed services.
Start here
Put AI to work in life sciences — with the right guardrails underneath.
Start with a structured AI Readiness Assessment: fixed-fee, executive-ready, and built to surface the highest-value workflows first.
- Workflow inventory and risk classification
- Business value and readiness scoring
- FDA CSA + EU AI Act + ISO 42001 gap analysis
- Prioritized 90-day roadmap by impact, risk, and effort