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1 Mar 2018

TraceLink's network approach gets pioneering German biotech EU FMD compliant

Barcode serial number serialization.

biosyn chooses a solution that ensures on-time compliance and delivers the required scalability.

To ensure compliance with the EU Falsified Medicines Directive (FMD) requirements, biosyn Arzneimittel has selected TraceLink’s serialization solutions.

As one of the first biotechnology companies in Germany, biosyn was founded in 1984 and specializes in keyhole limpet hemocyanin products and high-dose selenium injectable pharmaceuticals. Since its founding, the company has developed into a pharmaceutical enterprise with subsidiaries in Liechtenstein, Austria and the US, and has customers in over 25 countries.

With a large customer base in Europe, biosyn needed a serialization solution that would ensure on-time compliance with the EU FMD regulations through a simple and direct path to the European hub. As biosyn works with multiple contract manufacturers, the chosen solution would need to simplify connectivity and enable the seamless exchange of data. The solution also needed to meet requirements in South Korea, Brazil and other future markets.

“We have customers and partners located all over the world and could not afford to lose time and resources by establishing individual point-to-point connections. After a thorough evaluation of solution providers, it was clear that TraceLink’s network approach would deliver the scalability we needed while providing a simple and fast connection into the EU hub,” said Ortwin Kottwitz, CEO of biosyn.

“EU FMD compliance is becoming a stark reality for companies that need to have new technologies and processes fully implemented and connected into the EU hub by the February 2019 deadline. biosyn values our expertise on EU FMD and country compliance and chose TraceLink for its enterprise scalability and ability to simplify serialization challenges,” said Shabbir Dahod, CEO of TraceLink. “We look forward to partnering with the biosyn team to ensure they achieve EU FMD compliance and help them explore the wider potential of information sharing through digital network connectivity.”

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