The regulatory partner
your product deserves.
Today's pharma & medical device companies trust Deffai to navigate FDA approval complexity. Professional AI, with former FDA reviewer oversight.
Trusted by leading industry experts
Everything you need from
inception to FDA submission
From strategy to submission, every step of your product lifecycle is powered by precision, collaboration, and security.
01 — Regulatory Intelligence
Know regulatory trends, based on first-hand experience
In-depth analysis of FDA guidance trends and emerging review patterns with former FDA reviewer oversight.
- Trend analysis across recent FDA decisions in your specific product category
- Early signals on evolving review posture and guidance in development
- Proactive alerts when regulatory risk increases in your pathway
02 — Regulatory Strategy
Regulatory roadmap, guided by former FDA reviewers
Deffai analyzes your product's characteristics, intended use, clinical data and other information to generate a custom regulatory roadmap. With citations and validation by former FDA reviewers.
- 510(k), De Novo, PMA, IND, NDA and BLA pathways
- CMC strategy and risk assessment tailored to your product
- Predicate identification and substantial equivalence analysis
- Reviewed and signed off by a former FDA reviewer before delivery
03 — Special Programs
Identify special programs for faster review and approvals
Deffai models your eligibility for special programs based on your product profile, submission strength, and current FDA review trends. Fewer surprises and a clearer picture of what to expect.
- Approval probability scoring by pathway and product category
- INTERACT, RMAT, Fast Track, Breakthrough and other special programs
- Benchmarked against cleared and approved products with similar profiles
- Continuously updated as your submission evolves
04 — Submission Documentation
Get FDA submission documents and reports
Deffai generates the actual submission files based on your product data, not generic boilerplate. Every document is grounded in current FDA guidance, references relevant precedents with live citations, and is reviewed by your dedicated FDA expert before it leaves our platform.
- Technical files, summaries, labeling, and clinical evaluation reports
- Auto-cited against FDA guidance and comparable precedent filings
- Continuously updated as FDA guidance evolves
- Human expert review included — not optional — before every submission
05 — Human-in-the-Loop Support
A former FDA reviewer for human-in-the-loop support
Get a dedicated former FDA reviewer embedded in your engagement from day one. From reviewing AI outputs, attending your FDA meetings, to drafting correspondence and answering questions. Like a true team member
- Dedicated expert reviews every AI output before delivery — no exceptions
- Drafts and leads all FDA correspondence and deficiency responses
- Available for questions at every stage, like a true team member
Not a tool.
Not a consultant.
Your FDA team.
Traditional consultancies are project-scoped, manual and transactional. Generic AI platforms don't have the same nuanced thinking. Deffai gives you something unique: a former FDA reviewer who is embedded in your work with a professional AI platform specifically built for life sciences. Present for meetings, proactive on risks, personally accountable for outcomes, and available from 0 to 1.
Talk to an Expert| What you get | Traditional Consultancy | Generic AI Platform | Deffai |
|---|---|---|---|
| Dedicated FDA expert | Rarely | ✕ | ✓ |
| Embedded in your team | ✕ | ✕ | ✓ |
| Attends FDA meetings | Rarely | ✕ | ✓ |
| Leads FDA correspondence | Rarely | ✕ | ✓ |
| Cited AI outputs | ✕ | ✓ | ✓ |
| Regulatory trend intelligence | Limited | Limited | ✓ |
Meet our team
See full team →
Liz Wang
Cofounder & Chief Executive Officer
Laura C. Rose, PhD
Cofounder & Chief Regulatory Officer
Johnny Lam, PhD
Head of Regulatory Strategy
Built for the most regulated industry in the world
Every output from Deffai is grounded in verified regulatory data, reviewed by a former FDA expert, and cited to its source. No black boxes.
01
120,000+ Regulatory Precedents
Our models are trained on over 120,000 FDA filings, guidance documents, international standards, and regulatory decisions — the deepest regulatory training dataset available.
02
Every Output is Cited
We don't just give you answers — we show you the source. Every strategy, document, and recommendation includes verified citations to FDA guidance, precedent filings, and relevant standards. Fully auditable.
03
Human Review at Every Step
Every AI-generated output is reviewed by a former FDA reviewer before it reaches you. Accuracy is never left to the algorithm alone. This is built into our process, not an optional add-on.
04
Always Current Guidance
Deffai's knowledge base is continuously updated to reflect new FDA guidance, Q-Submissions, and evolving regulatory precedent. You are never working from outdated information.
05
Your Data Stays Yours
Enterprise-grade security. Your submission data, IP, and product information is never used to train models or shared with third parties. Full confidentiality, contractually guaranteed.
06
International Standards Coverage
Beyond FDA — ISO 13485, IEC 62304, ICH guidelines, and other international regulatory frameworks. Supports global market strategies alongside US submissions.
Built for two types of teams
Whether you're a consulting firm looking for a smarter internal tool or a company navigating FDA for the first time, Deffai meets you where you are.
Accelerate your practice. Reduce overhead.
CMOs, regulatory consultancies, and professional service firms use Deffai to expedite internal decision-making, scale expert capacity, and deliver faster, more defensible guidance to clients — without adding headcount.
- Instant precedent search across 120,000+ filings, with cited sources
- AI-drafted regulatory memos and strategy summaries
- Streamlined strategy development for client engagements
- Human expert backstop for high-stakes regulatory questions
- Reduce overhead on manual document review and research
From first strategy to FDA clearance — with your team.
Medical device manufacturers and drug sponsors work with Deffai for fully embedded, end-to-end FDA support. You get a former FDA reviewer as part of your team — present for meetings, leading correspondence, and accountable for outcomes.
- Customized regulatory pathway and CMC strategy before you submit
- Complete, cited submission documentation — AI-generated, expert-reviewed
- Predictive gap analysis to reduce deficiencies before filing
- Expert attends FDA meetings and leads all correspondence
- Critical FDA expertise embedded in your team from day one
Ready to move
faster through FDA?
Talk to a former FDA reviewer today. We'll map your regulatory path, identify your highest-risk gaps, and show you exactly how Deffai accelerates your submission timeline — no pitch deck, just a real conversation.
No commitment required · Speak directly with a former FDA reviewer