A curated regulatory corpus and a structured evaluation framework.
FDA Enforcement History
The full pattern of what FDA has actually cited, across therapeutic areas and channels.
OPDP Warning & Untitled Letters
Curated and structured so specific findings map to specific past actions.
FDA Statutes & Regulations
The FD&C Act and implementing regulations governing prescription drug promotion.
FDA Guidance Documents
Both draft and final guidance shaping how OPDP applies the rules in practice.
Judicial Precedent
Case law bearing on promotional regulation and enforcement.
Regulatory Principles
Fair balance, substantiation, adequate risk communication, avoidance of misleading net impression, and related principles.
Evaluation Gateways
Staged checkpoints materials pass through, mirroring how promotional review actually works.
Evidence Weighting
A methodology for scoring how directly a precedent or principle applies — findings ranked by strength, not treated as uniform.
Historical Precedent Mapping
Connecting specific claims and executions in your material to the enforcement actions and reasoning they most resemble.
Explainable Remediation Recommendations
Sourced suggestions for reducing identified risk — not just a flag. See how remediation output works →
A general model can describe FDA rules. It can't ground a finding in precedent.
A general-purpose model can describe FDA rules. It cannot ground a finding in a specific Warning Letter citing the same claim structure, weight that precedent against a weaker analogous citation, and show you the reasoning — the way someone who actually issued those letters would.
The curated corpus and evaluation framework were developed by a former FDA/OPDP Division Director with 15 years of enforcement experience, including expert witness testimony in landmark pharmaceutical promotion cases — not assembled by engineers guessing at what FDA cares about.
See it evaluate a real asset.
Bring a script, storyboard, or draft ad and see the corpus, the framework, and the citation trail in action.