FDA DSCSA Compliant

FDA Compliance, Solved

Meet DSCSA requirements in 15 minutes—not 18 months

Pharmaceutical supply chain compliance on blockchain. GS1 serialization, automated T3 documentation, and instant verification for $400/month.

80%
Faster Verification
$250K
Avg. Fine Avoided
15 min
Time to First Shipment
99.99%
System Uptime

The FDA's DSCSA Mandate Is Here. Are You Ready?

Every prescription drug in the US supply chain now requires full electronic traceability

Unit-Level Serialization

GS1-compliant Product Identifiers with NDC, serial number, lot, and expiration

Electronic T3 Documentation

Transaction Information, History, and Statements for every handoff

Real-Time Verification

Respond to verification requests in less than 1 second

6-Year Audit Trails

Immutable records accessible within 48 hours for FDA inspection

24-Hour Reporting

Suspect product quarantine and notification protocols

ATP Validation

Only deal with Authorized Trading Partners verified against FDA databases

The Penalty for Non-Compliance Up to $250,000 per violation Plus product quarantines and supply chain shutdowns

BizTrack Enterprise: DSCSA Compliance on Blockchain

$400/month vs. $100M+ custom systems. No technical complexity. No hidden fees. Just compliance.

1

Upload Your Data

CSV, Excel, or API integration. Product info, lot numbers, NDC codes—we accept standard formats.

2

We Handle Everything

Auto-generate GS1 barcodes, mint blockchain records, create T3 documentation. All automatic.

3

Ship With Confidence

Every product traceable, verifiable, audit-ready. One-click FDA exports anytime.

Enterprise Features Built for Pharma

Everything you need to stay compliant, secure, and audit-ready

GS1 Serialization

Generate compliant Product Identifiers with NDC, unique serial numbers, lot numbers, and expiration dates. Blockchain-backed and tamper-proof.

Blockchain Traceability

Every transaction recorded on XRPL—immutable, auditable, and unhackable. Unlike centralized databases, our system never goes down.

T3 Automation

Automatic generation of Transaction Information, History, and Statements. EPCIS 1.2+ interoperability for seamless supply chain events.

ATP Verification

Real-time validation against FDA databases. Block non-compliant transactions automatically before they happen.

Suspect Product Alerts

Automated quarantine workflows and 24-hour FDA reporting. Collaborate with trading partners on investigations seamlessly.

FDA Audit Exports

One-click compliance bundles with 6-year immutable records. XML, CSV, and PDF formats ready for inspection within 48 hours.

Cold Chain Monitoring

Track temperature deviations and maintain cold chain integrity. IoT sensor integration available for real-time alerts.

24/7 Support

Email support with 4-hour response times. Custom onboarding calls to map your supply chain and ensure smooth integration.

Legacy Systems vs BizTrack Enterprise

Feature
Legacy Systems
BizTrack
Initial Cost
$100M+
$400/month
Implementation Time
18-24 months
15 minutes
Data Security
Centralized (hackable)
Blockchain (impermeable)
Uptime Guarantee
99.99%
T3 Generation
Manual
Fully Automated
Per-Transaction Fees
Unlimited Usage
Technical Expertise Required
Zero

Stop Worrying About Audits. Start Shipping Confidently.

Get started in 15 minutes. No credit card required for demo.
First month 50% off with code DSCSA2025