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Tubilux selects TraceLink to achieve EU FMD compliance

Tubilux selects TraceLink to achieve EU FMD compliance

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TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced that Tubilux has selected TraceLink’s serialisation solutions to help its 30+ European pharmaceutical manufacturing customers comply with the rapidly approaching serialisation deadlines for the EU Falsified Medicines Directive (FMD).

Based in Italy, Tubilux is a pharmaceutical contract manufacturer that offers value added services for major and emerging pharmaceutical companies and specialises in ophthalmic products and services, including the manufacture of ointments, gels and eye drops for a wide range of eye disorders. Tubilux selected the TraceLink Life Sciences Cloud to enable its customers to meet the EU FMD regulations on-time, at the lowest cost and least risk to their product supply. By leveraging TraceLink’s network tenant architecture, Tubilux can eliminate the complexity and costs associated with point-to-point integrations for its EU pharmaceutical manufacturing customers.

“Our long-standing history in the international pharmaceutical and contract manufacturing industry has enabled Tubilux to become the benchmark in ophthalmology and preferred business partner for a number of Italian and international companies. In order to preserve our valued client relationships, we chose TraceLink for its market leadership and ability to help us seamlessly provide serialisation through a simple integration and wide breadth of interoperability with our partners,” said a Tubilux spokesperson. “With over 30 clients, we could not afford to lose time and resources by establishing individual point-to-point connections with each customer. TraceLink’s network approach instantly transformed our serialisation project into a much easier and more manageable process.”

“EU FMD compliance is becoming a stark reality for companies that need to have serialisation in place by the February 2019 deadline. The TraceLink Life Sciences Cloud platform provides companies with an easy and fast path directly into the EU Hub,” said Shabbir Dahod, president and CEO of TraceLink. “Tubilux values our deep expertise on EU compliance and chose TraceLink to simplify their serialisation while reducing their costs and minimising complexities with data exchange. We look forward to partnering with Tubilux to help ensure EU FMD compliance for their customers in Europe.”

TraceLink has already processed EU compliance reports for more than 660,000 units of product into the European hub, nearly 18 months ahead of deadline. The TraceLink European Union compliance module supports traceability reporting requirements from a single platform, providing customers with a tested integration to the European hub for reporting information about their product master data, serialised product pack data, and status changes for products targeted for distribution across all Member States.

To learn more about meeting global pharmaceutical compliance deadlines and how to build a flexible serialisation, track and trace, and reporting platform for the U.S., the EU, and other global regulations, please visit this link.

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