We don’t just build your strategy, we execute with you in real-life.

When you work with us, you get AI automated strategy optimized for your product and human-in-the-loop support. We’ll defend and represent you in FDA meetings.

We’re a team of ex-FDA, CMC, and Tech Ops leaders with 800+ successful submissions across IDE/IND, NDA, BLA, 510 (k), PMA, and De Novo.

See our service areas below.

Full FDA Support

    • Clinical & Regulatory Strategy

    • FDA In-Person Meeting Representation

    • Decision Logic & Regulatory Trends

    • Mock FDA Audits

    • 483 and Warning Letter Review

    • Site Due Diligence & Inspections

    • IND, BLA, 510 (k) Submissions

    • Program Management

    • Process Validation

    • CMC & Lifecycle Management

    • Control Strategy & CQA Development

    • Risk-based Approach

    • Process Characterization

    • Method Development

    • Method Validation

    • Stability Program Development

    • 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

Reviewed for IND, BLA, 510(k), PMA, and De Novo

800+ 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.

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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, Co-Founder & CEO