Success Story: Macure Pharma – change of serialization provider


We at tracekey are very happy about the feedback we receive from our customers for our software solutions and support. However, we were particularly excited about hearing the feedback from Macure Pharma. That’s because they took the effort to switch their serialization provider and chose us. Especially for a project as important as serialization, it […]

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Pharma Serialization in Argentina

Pharma Argentina

More and more countries are introducing regulations for the serialization of pharmaceuticals. South America is no exception. With around 422 million inhabitants, the continent has a population similar to the European Union and, with its emerging markets, is developing into an attractive market for exporters. Following our article on serialization in Brazil, here we summarize […]

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Advantages of WBDL in Tender Rounds

Vorteile durch WBDL/Advantages of WBDL

With consolidated shipment data (German: WBDL), hospitals can be relieved of a lot of work. Due to the EU Falsified Medicines Directive (FMD), just like in conventional pharmacies, all packaging of prescription drugs in hospital pharmacies must be scanned twice to guarantee their authenticity. The first time at delivery and then again at dispensing. WBDL […]

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Serialization Simplified – tracekey Serialization Manager

For Marketing Authorization Holders (MAH) and Contract Manufacturers (CMO) in the pharmaceutical industry, serialization is a recurring topic. Each batch must be provided with codes, which must be generated beforehand. For companies with high production frequency and generally more resources, this is usually not a problem. Since it is a regular task, one does not […]

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DSCSA Requirements for 2023

DSCSA Requirements

Beginning November 27th, 2023, FDA’s Drug Supply Chain Security Acts (DSCSA) requirements will change. In the future, pharmaceutical products in the USA will be required to be traceable at the lot and package level.  Moreover, part of the regulation also states that all parties must participate in data exchange, verification, and tracking of pharmaceuticals. For […]

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Cloud and cybersecurity in pharma

Cloud und IT Sicherheit

The cloud has become omnipresent. Whether we are streaming media, communicating with friends and colleagues, or simply storing data. Almost everything is done via cloud providers. But it often sounds like a buzzword to make something more interesting than it actually is. What exactly is the cloud? What types are there? And is it secure? […]

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Pharma Serialization in China

Pharma Serialisierung in China

As the country with the largest population, China also has one of the largest pharmaceutical markets in the world. In 2020 nearly 35 billion U.S. dollars were generated in pharmaceutical imports, and the trend is upward. In order to counteract counterfeiting and protect patients, the regulations of pharma serialization in China were adjusted in the […]

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Case Study: Stegemann (CPO) together with Level 3 partner Mettler Toledo

Case Study: CMO Stegemann + 3 Level provider Mettler Toledo

How does the cooperation between tracekey and the Level 1-3 providers work? We talked to one of our customers, Stegemann Lohnverpackung & Logistischer Service e.K. and the line manufacturer and Level 3 provider Mettler Toledo about our joint processes and work. The complete implementation of pharmaceutical serialization requirements, such as the EU FDM, includes not […]

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FAQ on Pharma Serialization

Efforts are being made worldwide to stop the dangerous trade of counterfeit medicines. To tackle this problem pharmaceutical serialization laws have now been enacted in numerous regions all over the world. Depending on the statutory requirement, serialization in the pharmaceutical industry is enforced differently. What all regulations have in common is the assignment of a […]

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