Regulatory intelligence, accelerated.
Deffai combines AI with decades of FDA expertise to help life sciences companies move through regulatory pathways faster and with greater confidence.
Most regulatory AI doesn't understand the FDA.
Ours was built by the people who worked there.
AI that covers the full regulatory lifecycle.
From strategy through submission to post-market compliance, our platform applies machine learning to the work that slows teams down most.
Regulatory Strategy Engine
AI-driven pathway analysis that evaluates your product profile against FDA precedent to recommend the optimal submission route, classification, and predicate strategy.
Submission Intelligence
Automated document review, gap analysis, and content generation for 510(k)s, PMAs, INDs, and more. Our AI flags deficiencies before the FDA does.
FDA Meeting Preparation
AI-assisted briefing document generation and question prediction based on historical FDA meeting patterns. Walk in prepared, walk out with alignment.
Why Deffai
We built Deffai because we saw too many promising therapies stall in regulatory limbo. Our founders spent years inside the FDA — reviewing submissions, shaping policy, and learning exactly what the agency expects.
That knowledge is now embedded in our AI. The result is a platform that doesn't just automate regulatory work — it understands it.
Ready to move faster?
See how Deffai can reduce your regulatory timeline and improve submission quality.