2 of 3 Companies with 2017 FDA Approvals Rely on TraceLink

Clinical-stage companies need to plan for commercialization and serialization—in parallel and at scale—to successfully execute their launch strategies and avoid costly gaps between commercial approval and DSCSA readiness. With so much at stake, Phase 3 companies are looking for a solution provider that offers a predictable path to serialization, reduces risk, and insulates them from the impact of regulatory changes.

That’s why, last year, a clear majority of companies relied on TraceLink as part of their commercialization planning:

• In 2017, 2 out of 3 of all companies that received FDA approval in the U.S. were TraceLink customers.
• 90% of all companies that had drugs approved in the U.S. in 2017 relied on the TraceLink network for exchanging compliance data.

Phase 3 planning: case study and best practices

Read the case study on how the IT and Supply Chain teams at Flexion Therapeutics prepared for serialization ahead of their 2017 market approval. And learn What Clinical-Stage Pharma Companies Should Know About Serialization.

A network built for streamlined data integration and partner onboarding

Because most Phase 3 companies don’t have the resources to cope with complex serialization challenges, they are partnering with TraceLink to integrate and exchange product data with just a single network connection—often with partners who are already on the TraceLink network. To date, nearly 400 pharmaceutical and contract manufacturing companies have selected TraceLink as their serialization solution—including more than 140 that are shipping serialized product today.