For Life Sciences Teams
From testing strategy to FDA submission,
accurate drafts in less time.
Whether you're bringing a medical device, drug, or biologic to market — Deffai gives you the regulatory infrastructure to move with transparency, predictability, and former FDA reviewer oversight from day one.
For Human Cells and Tissue-Based Products (HCT/P)
For Drugs & Biologics
For Medical Devices
361 HCT/P Regulatory Assessment
Validate your product's 361 HCT/P regulatory status with confidence. Our AI-powered assessment, built by ex-TRG reviewers with experience on 400+ submissions, delivers a complete 361 determination in 24 hours — catching classification errors before the FDA does.
Get Your 361 Assessment- Five-gate regulatory analysis: HCT/P status, exceptions, 21 CFR 1271.10(a) four-criterion test, labeling, and warning letter risk
- Benchmarked against GPT, Claude, and Gemini — Deffai delivers 100% accuracy where generic AI averages 73%
- FDA enforcement landscape analysis — flags warning letter patterns relevant to your product
- Expert-reviewed DOCX report with cited findings, delivered in 24 hours
- Built by former TRG reviewers who know exactly what goes behind FDA decision logic
INTERACT Meeting Preparation
End-to-end preparation for your INTERACT meeting with CBER. From readiness assessment and meeting type triage to briefing package generation, question scoring, and mock Q&A — so you walk into the FDA's earliest formal engagement fully prepared.
Prepare Your INTERACT Meeting- Readiness assessment — determines if INTERACT is the right meeting type vs. Pre-IND or Type D
- AI-drafted 50-page briefing package with CMC, pharmacology/toxicology, and clinical sections
- Question quality scoring — flags vague or overly broad questions that trigger FDA rejection
- Precedent analysis from our biologics corpus of BLA approvals, supplements, and FDA guidance
- Mock Q&A preparation based on historical FDA meeting patterns and review posture
- Former FDA reviewer reviews every deliverable before it reaches you
See Deffai
in action.
Whether you're validating a 361 HCT/P classification or preparing for your first INTERACT meeting, our former FDA reviewers will show you exactly how Deffai accelerates your regulatory path.
No commitment required · Speak directly with a former FDA reviewer