CuraTrace makes interoperable lot and serial tracing simple, affordable, and audit-ready for wholesalers, distributors, and manufacturers.
Serial number mismatch in shipment #12345
5 min ago • Auto-flagged for reviewNew shipment data received from Partner ABC
12 min ago • Processing completeBy 2025, every trading partner in the U.S. pharmaceutical supply chain must exchange interoperable EPCIS data to prove product traceability. Large pharma has enterprise systems in place, but small and mid-sized businesses are left scrambling.
Enterprise solutions like TraceLink or SAP ATTP cost more than most SMBs can afford, leaving them vulnerable to FDA penalties and audit failures.
Manual reconciliation of EPCIS files, ASNs, and serial numbers creates errors, delays, and compliance gaps that put your business at risk.
Most compliance solutions require weeks of setup, custom development, and ongoing maintenance that small teams can't handle.
A lightweight, AI-powered platform built for SMBs who need DSCSA compliance without the cost or complexity of enterprise solutions
Upload or forward EPCIS/ASN files to your CuraTrace inbox. Our AI automatically extracts, validates, and reconciles lot and serial data across your trading partners.
When discrepancies are found, CuraTrace automatically generates FDA-ready investigation packets and audit exports. No manual work required.
Just plug in, upload documents, and stay compliant. CuraTrace works with your existing email and file systems — no complex integrations needed.
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CuraTrace helps you meet the requirements of DSCSA and FDA regulations
Full compliance with FDA's Drug Supply Chain Security Act requirements for interoperable traceability
Built to handle EPCIS 2.0 data exchange and ASN processing for seamless partner integration
Complete audit trails and investigation packets ready for FDA inspections and partner disputes
Comprehensive tracking of serial numbers and lot codes across the entire supply chain
The DSCSA stabilization period is ending, and the FDA expects every trading partner to be ready. Don't get caught unprepared — CuraTrace helps you transition smoothly, avoid costly penalties, and keep trust with your partners.
✓ Early access • ✓ Priority support • ✓ Exclusive pricing
Have questions about CuraTrace? We'd love to hear from you. Send us a message and we'll respond as soon as possible.