Tjoapack Selects TraceLink to Achieve DSCSA & EU FMD Compliance for its EU Customers
TraceLink Inc., the World’s Largest Track and Trace Network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that Tjoapack has selected TraceLink’s serialization solutions to help its 50+ European pharmaceutical manufacturing customers comply with the rapidly approaching serialization deadlines for the U.S. Drug Supply Chain Security Act (DSCSA) in 2017 and the EU Falsified Medicines Directive (FMD) in 2019.
Tjoapack, a leading West-European contract packager for the pharmaceutical, biotech and medtech industries serving customers across the globe, has selected the TraceLink Life Sciences Cloud to enable its customers to meet the varying global regulations on-time, at the lowest cost and least risk to their product supply. By leveraging TraceLink’s network tenant architecture, Tjoapack can eliminate the complexity and costs associated with point-to-point integrations for its EU pharmaceutical manufacturing customers.
“As the market leader in the Benelux for pharmaceutical packaging and serialization, it was a natural fit to partner with TraceLink,” said Eric Tjoa, CEO of Tjoapack. “Their Life Sciences Cloud allows us to provide our customers a cost-effective and agile track and trace solution, well ahead of the U.S. and EU deadlines, while continuing to guarantee we deliver the highest quality of services. We offer both standard and bespoke solutions to our customers and only TraceLink has been able to accommodate the tailored data needs associated with the nature of our business.”
“The industry is beginning to place greater attention on EU FMD compliance, which introduces new complexities in serialization and government reporting. As a result, TraceLink is experiencing rapid customer adoption in Europe as companies realize that the proven Life Sciences Cloud platform provides them with an easy and fast path directly into the EU Hub,” said Shabbir Dahod, president and CEO of TraceLink. “Tjoapack values our deep expertise on EU compliance and chose TraceLink to help achieve multiple country regulations for serialization, keep costs low and meet the complex data demands of their customers – whether they have to comply with DSCSA, EU FMD, or both.”
Just 11 months from now, in November 2017, DSCSA regulations will require the serialization of all drug products and enhanced verification of product identity by pharmaceutical companies and their CMO/CPO partners. The first phase of this law, lot level tracing and verification, was enacted in January 2015. Since then, TraceLink has become the first and only solution provider to process over 170 million transaction history files for its customers.
Not far behind DSCSA, the EU FMD regulation will go into effect in 25 months, bringing considerable data management and business process challenges for organizations that do not have a comprehensive serialization strategy or the internal resources to cost-effectively build and maintain an architecture that can handle serialization. With the Life Sciences Cloud already integrated into the EU, TraceLink automatically facilitates serialized data for its customers into both the EU Hub and their national country databases. Additionally, TraceLink will begin hosting local data residency in the EU by early 2017, allowing global customers to utilize TraceLink’s unique network-tenant platform approach to significantly reduce the time, cost and risk of achieving regulatory compliance and eliminate the need to verify and certify point-to-point connections to each government system.
To learn more about meeting global pharmaceutical compliance deadlines and how to build a flexible serialization, track and trace, and reporting platform for the U.S., the EU, China, Brazil, South Korea, India, Turkey, Argentina and other countries, please visit www.tracelink.com.