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HCP Detail Aid
(rivantimab-jxkl) for injection, 100 mg/5 mL
Advanced Solid Tumors
AXIVARA demonstrated superior overall survival 1 vs. standard of care in patients with locally advanced or metastatic advanced solid tumors across two pivotal Phase 3 trials. 2
BEACON-1 Primary Endpoint: Overall Survival
First and only PD-L1-targeted therapy 5 approved for PD-L1-positive advanced solid tumors1
IMPORTANT SAFETY INFORMATION
BOXED WARNING: SEVERE INFUSION-RELATED REACTIONS. See full prescribing information for complete boxed warning. 6 Severe and fatal infusion-related reactions have occurred...
US-AXV-2500041 | Approved for use: Feb 2025 | For US Healthcare Professionals Only
The claim "superior overall survival" is a superiority/exclusivity claim requiring Phase III data citation with p-value and hazard ratio. Unsubstantiated superiority claims violate FDA promotional guidance.
Original
superior overall survival
Suggested
statistically significant improvement in overall survival (see BEACON-1 data)
Ref: PI Section 14, Clinical Studies
"Across two pivotal Phase 3 trials" implies both trials demonstrate the same endpoint. Cross-trial comparison without head-to-head data risks Lanham Act exposure.
Ref: Lanham Act Section 43(a); FDA Draft Guidance on Comparative Claims
"14.2 months" should cite the specific study population (PD-L1 2+ IHC, ≥75% tumor cells). PI Section 14.1 limits this result to the ITT population meeting expression threshold.
Four steps from upload to Veeva. Smart Intake classifies, links, reviews, and exports.
Drop any document. AI classifies it as promotional or reference material, auto-detects the brand, and routes it to the right workflow.
AI extracts every citation from your piece and matches them to uploaded references. A readiness dashboard shows what's linked and what's missing.
Five AI reviewers — Medical, Legal, Regulatory, Compliance, and Copy — analyze your material against 60+ checkpoints simultaneously.
Push reviewed documents to Veeva Vault pre-linked with reference relationships, annotations, and PromoMats metadata. No manual re-linking.
Each reviewer brings a specialized lens to your promotional material, just like a real MLR committee.
Validates clinical claims, checks citations against approved labeling, ensures scientific accuracy and appropriate data presentation.
Reviews for fair balance, comparative claims, trademark usage, IP risks, and potential Lanham Act or off-label promotion exposure.
Checks FDA/OPDP compliance, ISI prominence, indication scope, risk information adequacy, and 2253 filing requirements.
Verifies internal SOPs, material IDs, approval codes, version control, audience restrictions, and distribution channel appropriateness.
Everything you need to streamline your MLR review workflow.
View color-coded annotations directly on your promotional material. Each comment is linked to the specific text it references, categorized by reviewer type and severity.
Cross-review pattern analysis, confidence auto-tuning, disagreement detection, and "Why was this flagged?" explanations. The AI learns from reviewer decisions.
Claims registry with versioning, reference library with DOI/PMID, approved phrases, FDA guidance sync, and OPDP enforcement letter database for regulatory context.
Drop any PDF or paste text. AI classifies it across 18 material types, auto-detects the brand, extracts metadata, and routes promotional pieces vs. reference documents to separate workflows.
Upload documents individually and they link together automatically. AI extracts citations from promotional pieces, matches them to your reference library, and shows a readiness score before review.
Bidirectional sync with Vault: import documents, push annotations, map PromoMats metadata, and export documents pre-linked with reference relationships. No manual re-linking in Vault.
A/B test two AI models side-by-side, run multi-model consensus reviews with agreement scoring, and use incremental re-review to only process changed pages.
Daily sync of FDA OPDP enforcement letters from the Federal Register. Browse, import, and surface relevant enforcement actions during regulatory review for real-world compliance context.
Enterprise pharma review automation from intake to Veeva export. Here's where we are and where we're going.
Upload piece → AI reviews → View annotated output
AI-powered quality, content intelligence, and OPDP enforcement context
Smart Intake, auto-reference linking, Veeva integration, and multi-model AI
Enterprise-grade security, compliance, and scale
65+
D1 Tables
85+
API Routes
5
AI Reviewer Passes
60+
Review Checkpoints
Built on Cloudflare's full platform: Pages (SSR hosting), D1 (SQLite at the edge), R2 (object storage for PDFs), KV (session cache), and Queues (async review processing). Smart Intake uses AI to classify and route documents, auto-link citations to references, and stage materials with a readiness score before the review engine runs 5 specialized AI passes in parallel across 60+ pharmaceutical compliance checkpoints.
Catch compliance issues before your MLR committee does. Free to start, no credit card required.
