About us
We're rebuilding
GxP for the AI era.
compligen.AI was founded by Michael J. Gregor — a CSV/CSA leader with 37+ years of hands-on experience across pharmaceutical, biotechnology, medical device, and clinical research organizations — who got tired of spreadsheets, broken eQMS modules, and multi-year system validations.
50+
Customers in early access
12
Regulatory frameworks supported
6 wks
Average go-live
99.95%
Platform uptime
< 90 min
Average FDA walk-in
4.9 / 5
Customer satisfaction
Our story
compligen.AI was founded by Michael J. Gregor, a CSV/CSA leader with 37+ years of experience in FDA regulatory compliance, data integrity, and risk-based assurance strategies — validating GxP systems at companies like Pfizer, Sanofi, Abbott, Takeda, and 23 more organizations. Having been heavily involved in the FDA's Computer Software Assurance Guidance process, he decided to stop consulting on the problem and start building the solution.
cGen is the cGen AI-powered e-Validation platform he wished existed across every one of those 100+ engagements — with his 37+ years of regulatory expertise built directly into the logic of the cGen AI Assistant.
What we believe
cGen AI drafts, humans sign.
cGen AI is the world's best junior analyst — and that's exactly the role we give it. The qualified human signs every record.
Compliance is a feature, not a tax.
21 CFR Part 11, Annex 11, GAMP 5 and ALCOA++ should make your day easier — not weekly hell.
If your tool slows QA, you bought the wrong tool.
We measure success in inspection minutes, not Gantt chart length.
Leadership
Michael J. Gregor
Founder & CEO, Compliance Gurus & compligen.AI
37+ years in FDA regulatory compliance, CSV/CSA, data integrity, and 21 CFR Part 11 / Annex 11 compliance. Heavily involved in the FDA's Computer Software Assurance Guidance process. His extensive experience is built directly into the logic of the cGen AI Assistant.
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