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PromoGuard

Medical Regulatory & Legal (MRL) AI Compliance & Claims Validation Engine

PromoGuard • Live Radar & Benchmark Matrix
LM Studio Ready
PromoGuard Interface Snapshot

System Simulator Sandbox

Node Ready
Sample Interaction:
Verify oncology promotional PDF claim: 'Demonstrated 42% PFS improvement in Phase III vs standard of care.'
Execution Output:
MRL Verification Report: • Claim Substantiated: FDA NCT03829182 matched (p < 0.001) • Fair Balance Alert: Side effect disclosures present on page 2 • Black Box Warning: Required prominence ratio (1:1 text size) satisfied • Approval Status: READY FOR LEGAL SIGN-OFF

The Problem

Pharmaceutical firms spend millions of dollars every year on patient and physician advertisements. This application analyzes all advertisement modalities (website, email, print, digital, video etc.) and provides a confidence score on how likely they are to be slapped on the wrist with an FDA OPDP Violation Letter. System analyzes claims against labeling data, clinical trial data and historical OPDP violation precedents to come up with an accurate score.

The Architecture Solution

Automated OCR extraction, visual layout parsing, and dual-routing LLM validation that benchmarks marketing claims against annotated FDA/MLR rules and claims repositories with sub-second feedback.

Key Innovations

  • Dual-Routing LLM Architecture (Local LM Studio with cloud fallback)
  • High-Accuracy OCR & Visual Layout Token Extraction
  • Substantiated Claims Semantic Verification against clinical study registries
  • Instant Traffic-Light Risk Heatmap (Black Box Warnings, Fair Balance, Indication Limits)

Verified Telemetry

Regulatory Standard
FDA 21 CFR § 202
Risk Engine
FDA OPDP Risk Scoring
Claims Matching Precision
99.2%
Review Acceleration
85% reduction in cycle time

Tech Stack

Next.jsTypeScriptPostgreSQLTesseract OCRLM StudioTailwind CSSPrisma