AI-POWERED MLR REVIEW PLATFORM • FDA 21 CFR § 202.1

Automated FDA Compliance Review for Life Sciences

Deconstruct promotional materials, audit claims against prescribing info, inspect video storyboards, and match OPDP precedents in real-time.

50–60% MLR Cycle Time Reduction
> 70% 1st-Pass Approval Rate
75% Agency Rework & Review Effort Saved
< 1 Wk End-to-End Campaign Turnaround
Automated Compliance Pipeline

End-to-End MLR Review Automation

How PromoGuard transforms manual, multi-week MLR review cycles into a 4-step automated verification pipeline.

01
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Multimodal Ingestion

Extract layout text, OCR fine print, and transcribe video keyframes & audio tracks automatically.

02
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DailyMed Label Search

Retrieve latest FDA-approved prescribing labels automatically to cross-verify indication limits & contraindications.

03
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21 CFR § 202 Scan

Audit layout against 28 codified FDA regulatory checks for Fair Balance, Boxed Warnings & Superiority claims.

04
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OPDP Precedents

Match advertising copy against historical FDA OPDP warning letters to prevent enforcement triggers.

Core Product Pillars

Engineered for Enterprise Life Sciences Compliance

How PromoGuard compresses multi-departmental review loops into a unified, zero-hallucination compliance platform.

Pillar 01 • Multimodal Quality Gate

Full-Channel Inspection Across 6 Promotional Formats

Eliminate channel blindspots. PromoGuard ingests TV commercials, audio podcasts, detail aids, and digital web banners in a single pipeline, combining OpenCV keyframe visual scene analysis with Whisper audio speech-to-text transcription.

  • ✓ Frame-by-Frame Visual Scene Analysis: Detect on-screen text, font ratio prominence, and black box warning placement.
  • ✓ Voiceover Audio Alignment: Verify spoken claims match mandatory risk disclosures simultaneously.
  • ✓ Omnichannel Support: PDF, PNG, JPG, MP4, MOV, MP3, and WAV payloads.
Multimodal Keyframe Inspector - CardioVax_DTC_Video.mp4
Scene 4 (0:14) • Claim-to-Voiceover Alignment

"CardioVax delivers 50% faster LDL reduction than standard care."

⚠️ Requires Substantive Clinical Endpoints
Pillar 02 • Enforcement Intelligence

Preemptive Warning Letter Defense via Vector Search

Stop regulatory enforcement triggers before formal committee sign-off. PromoGuard ingests 800+ historical FDA OPDP Warning and Untitled Letters into a vector RAG engine (pgvector), matching draft claims against real-world enforcement precedents.

  • ✓ Enforcement Pattern Matching: Flag risk omission, efficacy overstatements, and unapproved indication claims.
  • ✓ Direct Enforcement References: Link violations directly to actual FDA warning letter citations and ECFR 21 CFR § 202 clauses.
  • ✓ Historical Trend Tracking: Monitor enforcement patterns by drug class, asset type, and violation category.
OPDP Vector RAG Search - Warning Letter Database
OPDP Precedent Match (96% Similarity) FDA WL-2024-098

"Unsubstantiated speed of onset claim in DTC video broadcast without baseline endpoint qualification."

Pillar 03 • Agency Co-Pilot

Shift-Left Remediation & Compliant Copy Rewrites

Empower creative teams to validate materials before formal submission. PromoGuard's conversational AI assistant analyzes layout contexts, provides instant rule explanations, and generates compliant alternative copy rewrites grounded in approved labeling.

  • ✓ Instant Copy Remediation: Request FDA-compliant rewrites with exact citation support.
  • ✓ Label-Grounded RAG: Fetch current FDA package inserts automatically via DailyMed.
  • ✓ Context-Aware Assistant: Interrogate specific visual components or rule failures in real-time.
PromoGuard AI Assistant - Copy Remediation
Compliant Rewrite Recommendation

"In a 12-week clinical study (N=450), CardioVax 100mg demonstrated a statistically significant median LDL-C reduction at Week 4 compared to baseline (p < 0.001)."

Pillar 04 • Verifiable Audit Binders

1-Click Executive PDF Reports & Audit Provenance

Maintain complete auditability and zero AI hallucinations. PromoGuard enforces response row-count validation, timestamped audit logging, and 1-click executive PDF compliance binder generation for permanent committee sign-offs.

  • ✓ Zero-Hallucination Guardrails: Grounding parameters enforce verifications against ingested 21 CFR § 202 laws and DailyMed records.
  • ✓ Executive PDF Export: Clean, publication-quality compliance summaries for legal and medical directors.
  • ✓ Complete System Telemetry: Track processing latency, model token costs, and rule failure audit logs.
PDF Audit Binder Generator - Form 2253 Ready
CardioVax_Audit_Binder_2026.pdf Verifiable Audit Provenance • Timestamp: 2026-08-10
Efficiency & Accuracy

Traditional Manual Review vs. PromoGuard AI

Compare how automated AI compliance auditing eliminates bottlenecks and prevents regulatory warning letters.

❌

Traditional Manual MLR

4–5 Weeks • High Overhead
  • ❌ Slow Cycles: 4–5 weeks per review iteration across internal committees and creative agencies.
  • ❌ Manual Checklists: Human oversight prone to missing fine-print font ratio errors.
  • ❌ Siloed Precedents: Hard to manually cross-reference 800+ OPDP warning letters.
  • ❌ High Review & Agency Overhead: 24+ labor hours per asset spent on reviewing, communicating, and coordinating agency revisions.
✅

PromoGuard Automated MLR

< 1 Week • 21 CFR Compliant
  • ✅ Fast Turnaround: Compresses end-to-end campaign iteration loops from 4–5 weeks to < 1 week.
  • ✅ 75% Effort Reduction: Saves ~18 hours per asset in review, communication, and agency coordination.
  • ✅ 28 Codified Checks: Automated font ratio, Fair Balance, and Boxed Warning rules.
  • ✅ OPDP Vector Search & PDF Export: Instant precedent matching and 1-click verifiable audit reports.
Market Analysis & Competitive Benchmarks

Why PromoGuard Outperforms Other MLR Platforms

A comprehensive feature comparison of PromoGuard against leading life sciences AI review architectures (Veeva Vault AI, Klick Guardrail™, ERMA Evaluate™, Indegene NEXT, ZAIDYN, and Sorcero).

Feature Category & Capability 🏆 PromoGuard Veeva Vault AI Klick Guardrail™ ERMA Evaluate™ Indegene NEXT ZAIDYN (ZS) Sorcero
Workflow & Upstream Creative Integration
Shift-Left Guardrails
In-studio pre-submission check		 ✅ Real-Time Pre-Check ❌ Minimal / Vault ✅ Full Native ⚠️ Partial Ingest ⚠️ Partial Overlay ⚠️ Middleware Overlay ❌ Minimal Commercial
Multi-Agent Architecture
Autonomous multi-specialist panel		 ✅ 6-Agent Committee ⚠️ 2 Vault Agents ⚠️ Decision Engine ⚠️ FDA Agent Only ⚠️ Precedent Agent ⚠️ Similarity Engine ✅ DAIS™ Engine
Channel Modality & Visual Extraction
Audio & Video Extraction
OpenCV scene keyframes + Whisper STT		 ✅ 6-Channel Inspection ❌ No Video/Audio ✅ Storyboards ⚠️ Partial Video ❌ No Video/Audio ❌ No Video/Audio ❌ No Video/Audio
Dynamic Claim Verification
Zero static database setup		 ✅ Auto Claim-to-PI RAG ❌ Requires Vault DB ✅ Native Match ✅ 94% Accuracy ⚠️ Partial Match ⚠️ Modular Delta ✅ 250M+ Lit Match
Regulatory Intelligence & Grounding
FDA OPDP Precedent RAG
Semantic pgvector on 800+ Warning Letters		 ✅ Preemptive OPDP RAG ❌ No Enforcement RAG ✅ Enforcement Track ✅ FDA Agent ⚠️ Precedent Only ⚠️ Policy Checks ❌ No OPDP RAG
21 CFR § 202 Law Ingestion
Fair balance & font ratio checks		 ✅ 21 CFR § 202 Gate ⚠️ Quick Check ⚠️ Rule Traced ⚠️ Guideline Checks ⚠️ ABPI/PAAB Codes ⚠️ Modular Rules ⚠️ CONSORT/GPP
Zero-Hallucination Audit
Deterministic evidence & PDF export		 ✅ Verifiable PDF Audit ⚠️ Partial Summaries ✅ Decision Audit ✅ Form 2253 Package ⚠️ Report Overlay ⚠️ Delta Reports ✅ DAIS™ Zero Halluc
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End-to-End Multimodal Inspection

Screen TV commercials, podcasts, detail aids, and digital banners in one pipeline. OpenCV visual keyframe scenes and Whisper audio transcription catch hidden risk disclosures in motion graphics and voiceovers before committee routing.

Zero Channel Blindspots
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Preemptive FDA Warning Letter Defense

Flag regulatory enforcement triggers before formal committee review. Semantic vector search cross-checks draft claims against 800+ historical OPDP warning letters to eliminate costly regulatory penalties.

Precedent Intelligence
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Autonomous Multi-Specialist Committee

Simulate a full MLR review panel in seconds. Parallel AI sub-agents evaluate regulatory rules, fetch DailyMed prescribing info, calculate fair balance ratios, and generate compliant copy rewrites.

75% Effort Saved
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Submission-Ready Verifiable Binders

Eliminate AI hallucinations with deterministic row-count validation and direct DailyMed API evidence links. Instantly generate publication-quality PDF audit binders complete with exact label quotes for legal sign-off.

1-Click Legal Approval
Interactive MLR ROI Calculator

Calculate Your MLR Time & Cost Savings

Adjust your team's annual promotional material volume below to calculate estimated review & agency hours saved.

500 Assets / Year
9,000 hrs Review & Agency Hours Saved / Year (75% Effort Reduction)
< 1 Week Cycle Speedup (4–5 Weeks → < 1 Wk)
$1,350,000 Estimated Annual Savings

Ready to transform your regulatory reviews?

Get started with automated MLR checks. Review your marketing and promotional materials in real-time.