Intake
Submit the material — script, storyboard, print ad, social post, website copy, leave-behind, or video — along with context: indication, claims being made, target audience, and channel.
Claim & Element Extraction
The platform identifies the discrete promotional claims, presentations, and risk-relevant elements — the units FDA actually evaluates individually.
Precedent Cross-Reference
Each claim and element is checked against the curated corpus: enforcement letters, statutes, regulations, guidance, and case law.
Regulatory Principles & Evaluation Gateways
Findings run through a structured framework of gateways — fair balance, substantiation, risk presentation, net impression — rather than one collapsed score.
Evidence Weighting & Risk Output
Each finding is weighted: a direct precedent match, an analogous case, or a general regulatory principle with no direct citation. Full citation trail included.
Explainable Remediation
Sourced, specific suggestions for reducing each identified risk — often more than one defensible option.
Handoff to MLR & Legal
The structured output feeds into your existing MLR and legal review process. It informs that process — it does not replace it, and issues no approval or rejection.
The output is a citation trail, not a black-box score.
Every risk finding traces back to the specific precedent, statute, regulation, or guidance passage behind it — tiered by how directly it applies. That's what makes it usable in a regulated environment: your team can see the reasoning, not just the conclusion.
MLR, legal, and regulatory sign-off remain yours.
OPDP Intelligence informs your review process. It does not sit in place of MLR, legal, or regulatory review, and it does not issue approvals or rejections.
See it on your materials.
Walk through the full seven-step process on a real promotional asset.