AI Regulatory Strategy
For life sciences and service providers in biologics, drugs, and devices. Accelerate clinical trial and FDA approvals with AI built on decades of FDA expertise.
One Integrated Platform
with Full FDA Support.
Get strategic framework optimized for your product and human-in-the-loop support. We’ll defend and represent you in FDA meetings.
PLATFORM
We Give Lean Teams Superpowers.
Deffai streamlines your clinical pipeline by providing AI-powered advisory work. We amplify your team and give them the confidence and speed for a successful drug market entry.
1
Draft Documents & Anticipate FDA Feedback
Transform your regulatory strategy, anticipate FDA responses, optimize cost and timeline with our AI automation platform.
2
Customized Clinical & Go-to-Market
We provide comprehensive go-to-market support integrating different teams including Regulatory, Validation, Clinical, Tech Ops, and CMC.
3
Real-time Regulatory Monitoring & Updates
Delegate complex Regulatory & CMC tasks. Custom-built for your drug product from preclinical to commercial.
The New Standard in FDA Approval.
Deffai is the first AI-native platform built for biopharma critical decisions. From preclinical to commercial, we adapt to your ways of working and scale effortlessly with your team.
SOLUTIONS
Built for All Teams.
Grounded in FDA guidance and industry standards, we combine AI with expert oversight ensuring the highest standards of quality and accuracy.
Biotech
Enterprise-grade guidance and flexible engagement without the overhead. We scale with your pipeline from pre-IND to commercial.
Pharma
Seamless collaboration across teams. Align decisions on one integrated platform so you reach the next milestone faster.
CMO & Consulting Firms
Streamline client projects and strengthen commercial relationships with a customized platform.
OUR PROMISE
We founded Deffai with a simple conviction. AI will fundamentally transform how things are done in the biotech and pharmaceutical industry.
The knowledge required to scale and navigate clinical programs have historically been scattered and kept behind institutional walls.
Deffai is building a system to capture and democratize institutional knowledge because scientific excellence shouldn’t be gated by operational complexity.
We’re collapsing barriers, giving lean teams superpowers to bring life-saving medicine to patients faster.
Liz Wang, Co-Founder & CEO
San Francisco, 2025
WORK WITH US
Let’s Get You Across The Finish Line.
We have a flexible engagement model for teams of all sizes: get hands-on consulting support and/or access our AI-powered automation platform.
Hands-On Consulting
Access our multidisciplinary team of ex-FDA and industry veterans for: Regulatory Strategy, Submissions (IDE/IND, NDA, BLA, 510(k), PMA, and De Novo), CMC, Tech Transfer, and Process Validation.
We provide in-person representation for your FDA meetings.
Automation Platform
Grounded in FDA guidance, scientific literature, and real-world cases, Deffai is built on sources you can trust. Get in-depth answers to Regulatory, CMC, and Tech Ops with precise citations.
Get a free consultation on how your team can benefit from our platform.
Ready to optimize your regulatory pathway?
Email us directly at info@deffai.com, or fill out the form below.