About Deffai
Built by regulators,
powered by AI.
We started Deffai because we believed AI could fundamentally improve how life sciences companies navigate regulation — if it was built by people who actually understood the FDA.
Deffai was founded by industry experts and former FDA leaders who spent years reviewing submissions, shaping policy, and watching promising therapies stall due to misaligned strategies and incomplete filings.
We saw an opportunity to apply AI to the problem, using it as a tool built on deep regulatory domain knowledge. Our models are trained on decades of FDA guidance and review patterns, validated by the same people who used to sit on the other side of the table.
The result is a platform that helps life sciences companies move faster, reduce risk, and build stronger submissions at every stage.
The principles behind every decision we make
01
Rigor
Every model we build is validated against real-world regulatory outcomes. We hold our AI to the same standard the FDA holds submissions.
02
Transparency
Our AI shows its reasoning and cites its sources. Regulatory teams can verify every output — no black boxes.
03
Speed
Regulatory timelines are already too long. We compress weeks of work into hours without cutting corners on quality.
Wherever FDA is involved, Deffai delivers
Medical Devices (Class I–III)
Pharmaceuticals & Biologics
In Vitro Diagnostics
Combination Products
Digital Health & SaMD
Cell & Gene Therapy
See what AI can do for your
regulatory team.
Schedule a conversation with a former FDA reviewer. No commitment required — just a real discussion about your regulatory path.