AI-powered regulatory solutions.
Purpose-built AI that understands FDA expectations, trained by the people who used to set them.
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.
Compliance Monitoring
Continuous AI surveillance of regulatory changes, post-market requirements, and quality system obligations. Stay compliant without the manual overhead.
Clinical Evidence Planning
AI models that analyze clinical study designs against FDA acceptance criteria to optimize your evidence strategy and reduce the risk of clinical holds.
Global Regulatory Intelligence
Automated cross-jurisdictional analysis across FDA, EU MDR, Health Canada, and other frameworks to identify the fastest path to worldwide market access.
How it works
Getting started is straightforward.
01
Connect
Integrate your existing regulatory documents and product data. Our AI ingests your portfolio and builds a comprehensive regulatory profile in minutes.
02
Analyze
Our models evaluate your regulatory landscape — identifying optimal pathways, flagging risks, and benchmarking against thousands of prior submissions.
03
Accelerate
Get actionable intelligence, AI-drafted documents, and expert-validated recommendations that compress months of regulatory work into days.
See Deffai in action.
Every product is different. Tell us about yours and we'll show you exactly how our platform can help.