Case Study: Flexion Therapeutics achieves early serialization readiness with TraceLink

Why Phase 3 Flexion Therapeutics Seized On Serialization Early

Flexion Therapeutics, a clinical-stage biopharma preparing its first commercial launch, needed to address DSCSA serialization early while also building out its supply chain from the ground up. With limited internal resources and a tight timeline before FDA approval, the company wanted a proven partner to help meet serialization requirements at launch.

Flexion Therapeutics selected TraceLink as its EPCIS vendor and implemented serialization in parallel with commercialization planning, starting educational work 15 months before PDUFA, vendor review 13 months out, and implementation 9 months before. By partnering with TraceLink, Flexion positioned itself to launch in compliance with DSCSA and join the many FDA-approved companies already operating on the TraceLink network.

Flexion Therapeutics

John Kuczek

Senior Director of Supply Chain