Optimize your FDA outcomes.
Increase your approval probability with AI built on precedent and the precision of former FDA reviewers.
Simulated FDA reviews to increase your approval probability.
Redefining regulatory intelligence
* Measured on 220+ FDA submission cases using six statistical methods including Wilson Score CI, McNemar's, and Cohen's Kappa. Full report available upon request.
Why customers choose Deffai.
Closed gaps in IND submission
Deffai provided technical and thorough assessment from the lens of former FDA reviewers. Successfully identified and closed gaps for a gene-therapy IND submission.
IND review for AAV gene therapy combination product for genetic disorders.
Prevented a clinical hold
Deffai prevented a potential clinical hold after reviewing INTERACT package, gave a small team the technical depth of a former FDA director.
INTERACT assessment for human tissue extract for neurodegenerative indication.
Surfaced critical Pre-BLA gaps
Deffai identified critical deficiencies after reviewing Phase 2/3 clinical data, and supported a better preparation of pre-BLA meeting.
Pre-BLA clinical assessment for Phase 2/3 study for oncology.
Senior regulatory partner
for your in-house teams.
We are former FDA reviewers and decision-makers across CBER, CDER, and CDRH with 100+ years of experience across cell & gene therapy (CGT) including mRNA, AAV, ADC, immunotherapies for vaccines, oncology, regenerative medicine and tissue engineering for medical device and combination products.
We started Deffai to help teams understand and anticipate FDA expectations, so lifesaving medicines and devices can get to market faster.
The top teams use Deffai for
Tissue Reference Group requests to confirm whether your HCT/P is regulated under Section 361 or 351 — framed the way FDA expects to see them.
Donor eligibility determinations — screening, testing, and documentation under 21 CFR 1271 — reviewed against current FDA expectations.
Pre-submission INTERACT package review to surface the questions and deficiencies the FDA is likely to raise — before your meeting.
A second pair of former-FDA eyes on your Pre-IND briefing package, with a clear read on alignment and the gaps to close.
Full IND submission review against precedent and current FDA expectations, validated by a former reviewer in your product type.
Analytical characterization, potency assays, and comparability — reviewed by former FDA CMC reviewers who set the bar.
Protocols and study results checked for FDA alignment, from Pre-IND through Phase 2/3 and pivotal readouts.
RMAT, Breakthrough Therapy, and Fast Track designation strategy and the supporting packages that hold up to FDA scrutiny.
Pre-BLA meeting preparation and gap assessment for late-stage and controversial programs heading into submission.
Tissue Reference Group requests to confirm whether your HCT/P is regulated under Section 361 or 351 — framed the way FDA expects to see them.
Donor eligibility determinations — screening, testing, and documentation under 21 CFR 1271 — reviewed against current FDA expectations.
Pre-submission INTERACT package review to surface the questions and deficiencies the FDA is likely to raise — before your meeting.
A second pair of former-FDA eyes on your Pre-IND briefing package, with a clear read on alignment and the gaps to close.
Full IND submission review against precedent and current FDA expectations, validated by a former reviewer in your product type.
Analytical characterization, potency assays, and comparability — reviewed by former FDA CMC reviewers who set the bar.
Protocols and study results checked for FDA alignment, from Pre-IND through Phase 2/3 and pivotal readouts.
RMAT, Breakthrough Therapy, and Fast Track designation strategy and the supporting packages that hold up to FDA scrutiny.
Pre-BLA meeting preparation and gap assessment for late-stage and controversial programs heading into submission.
Enterprise standard
SOC 2 aligned. No AI training on your data. Built for the confidentiality demands of the leading biotech teams.
SOC 2
SOC 2-aligned controls across every system and process that touches your data.
AES-256
Your data is encrypted at rest with AES-256 — the standard trusted by financial institutions.
TLS 1.3
Everything in transit is encrypted with TLS 1.3, secure from your browser to our servers.
SSO & MFA
Enterprise authentication with single sign-on and multi-factor, so only your team gets in.
Zero training
We never train AI on your data. Your submissions and IP stay yours, full stop.
Frequently asked
How is Deffai different from a traditional regulatory consulting firm?
Traditional consultants offer individual perspectives across broad areas. Deffai's AI and regulatory database are purpose-built on qualitative FDA opinion for the pace fast-moving companies need, and every assessment is validated by former FDA reviewers — broader insight, at a fixed cost.
Do you use customer data to train your AI?
No. We do not allow third parties, including foundation models, to train on your data. We use it only to learn your business context.
How does pricing work?
Fixed price, quoted upfront based on the regulatory milestone. Transparent pricing — no hourly billing, no surprises.
How do we work with you?
It starts with a free initial consultation to understand your product. From there, a dedicated former FDA reviewer with expertise in your area works with you throughout the program.
What product types do you cover?
Drugs, biologics and combination products. For drugs and biologics, we specialize in IND to BLA or NDA pathways with a special focus on CMC strategy and special program eligibilities such as RMAT and Breakthrough Designations. For TRG and donor eligibility, we can help you make an eligibility assessment or submission quickly. If you're unsure, please reach out and we'd be happy to chat.
Can Deffai represent us in front of the FDA?
Yes, we can attend your FDA meetings as your representative. Our team is experienced with FDA interactions across meeting types.
Where do you operate?
US, China, EU, and Canada.