What's inside
- What FDA, EMA, NIST, and the EU are signaling on evidence, oversight, and lifecycle control
- Where AI fits across discovery, clinical, regulatory, and operations work, and where agents raise the risk
- A four-level maturity model and a practical 90-day path from pilots to governed capability
- A ten-question scorecard for finding the operating constraint closest to the decision
Built from FDA, EMA, NIST, EU and NIH materials, a UK government survey, peer-reviewed research, and clearly attributed industry surveys.