A pharmaceutical manufacturer needed to comply with DSCSA serialisation requirements and eliminate counterfeit drugs from its supply chain.
Team
6 blockchain engineers + 2 regulatory specialists
Timeline
20 weeks end-to-end
Client
Pharmaceutical Manufacturer (Global)
Outcomes Delivered
100%
DSCSA Compliance Achieved
0
Counterfeit Incidents Post-Launch
4 days → 2 hrs
Recall Response Time
Mapped the full drug supply chain from manufacturing through distribution to pharmacy, identifying all 8 serialisation data capture points.
Implemented GS1-compliant 2D barcode serialisation at the unit, case, and pallet level, integrated with the manufacturing execution system.
Built a blockchain network with nodes for the manufacturer, 12 distributors, and a regulatory observer node for real-time compliance monitoring.
Developed a recall response system that can identify and quarantine all affected batches across the entire network within 2 hours.
Achieved DSCSA compliance certification from an independent auditor before the regulatory deadline.
Implemented a blockchain-based drug traceability platform covering manufacturer, distributor, and pharmacy nodes with DSCSA compliance reporting.
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