Technical Capabilities
Our team is made up of ex-FDA and industry veterans with 100+ successful submissions across IND, BLA, 510 (k), PMA, and De Novo. Dual headquartered in San Francisco, CA and Washington D.C., we provide hands-on support from preclinical to commercial.
See our service areas below.
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Mock FDA Audits
483 and Warning Letter Review
FDA Enforcement Logic
Site Due Diligence & Inspections
Global Regulatory Strategy
IND, BLA, 510 (k) Submissions
Compliance & Approval Support
Program Management
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Process Validation
CMC & Lifecycle Management
Control Strategy & CQA Development
Risk-based Approach
Process Characterization
Method Development
Method Validation
Stability Program Development
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Site Selection
Comparability Strategy
Tech Transfer & Facility Fit
Scale-up Planning
Multi-site CMO Management
Vendor Selection & Qualification
Person-in-plant (PIP) Support
Budget & Resource Management
Med Device, Combination Product, Drug, Biologic
4+ Domains
50+ Years
Combined Regulatory, CMC, Tech Ops Expertise
IND, BLA, 510(k), PMA, and De Novo Submissions
100+ Filings
Across Drug, Biologic, and Device Facilities
200+ Inspections
GET IN TOUCH
Ready For a Smarter, Faster Clinical Program?
Engage our ex-FDA and industry veterans directly. Book a free consultation to see how we can optimize your FDA approval pathway.
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.
San Francisco, 2025
Liz Wang, Founder & CEO