Transform PV Case Intake with Validated AI

Process any document in any language. Generate ICH E2B(R3) XML in minutes, not hours. First AI-generated ICSR submitted to EMA.

🛡️ ISO 27001
✅ SOC 2
🇪🇺 EU Hosted
🔐 Dedicated Isolated Sandbox
🗑️ Delete Anytime
🚫 Never Trains AI
100%
Data Isolation
24/7
Delete Access
95%
Validated Accuracy
10x
Faster Processing

Enterprise-Grade Features

Built for pharmaceutical companies, validated for regulatory compliance

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Any Document Format

Process PDFs, emails, faxes, handwritten notes. Our AI handles 100+ languages with medical terminology.

E2B(R3) Validation

Generate ICH-compliant XML with built-in business rules validation. Export to Argus, Veeva, ARISg.

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21 CFR Part 11

Complete audit trails, e-signatures, role-based access. SOC 2 Type II and ISO 27001 certified.

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Human-in-the-Loop

Review and edit before submission. Track changes, add comments, maintain full control.

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MedDRA Coding

Automatic coding to latest MedDRA version. WHO-Drug dictionary integration available.

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Global Compliance

GDPR, HIPAA compliant. Data residency in EU or US. Your data never trains our models.

Simple 3-Step Process

From document upload to validated E2B(R3) in minutes

How it works

"A Milestone in Pharmacovigilance: Wörwag Pharma submits its first AI-generated ICSR to the EMA"

— Reinhold Schilling, Head of Global Pharmacovigilance, Wörwag Pharma

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