The FDA just cited a manufacturer for trusting AI without verifying its work. Your team is already using AI today — can their output survive a compliance review tomorrow?
AI adoption in regulated life sciences requires more than productivity tools—it requires a quality system your compliance team can trust. SciGen exists to close that gap.
The CRAFT™ Quality System is a closed-loop methodology—from structured input (CRAFT™) through validated output (VERIFY™) to measured quality (Scorecard™) and proven impact (CRAFT Lift™). It's the only AI training built like a quality management framework.
VERIFY™ maps to 6 of 10 principles from the January 2026 FDA/EMA joint guidance on AI in drug development. When regulators ask how your team validates AI output, VERIFY™ is the answer—producing documented audit trails, not just better prompts.
Big consultancies leave you a strategy document. We leave your leaders able to run the CRAFT™ quality system on their own real work—the next day and every day after. The capability stays inside your organization, not ours.
A research-backed, four-layer closed loop: Structured Input → Validated Output → Measured Quality → Proven Impact
Hands-on AI capability for the leaders who run life sciences. Start with a diagnostic, or go straight to a working session with your team.
Founding Client Rates — 2026
Only 9% of companies see ROI from AI (Accenture). The gap is methodology, not technology. We're taking a limited number of founding engagements at founding rates — a Diagnostic Sprint or Executive AI Workshop built entirely around your team's real work.
Thank you for your interest in SciGen Learning. We'll review your application and reach out within 24 hours to discuss next steps.