TraceLink's network approach gets pioneering German biotech EU FMD compliant
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.”
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance