Tubilux Selects TraceLink to Achieve EU FMD Compliance
TraceLink announced that Tubilux has selected TraceLink’s serialization solutions to help its 30+ European pharmaceutical manufacturing customers comply with the rapidly approaching serialization 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 specializes 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 serialization 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 serialization project into a much easier and more manageable process.”
“EU FMD compliance is becoming a stark reality for companies that need to have serialization 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 serialization while reducing their costs and minimizing 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, serialized product pack data, and status changes for products targeted for distribution across all Member States.