Who We Are
We are agile, committed and dedicated team players. We are experts for digitalization in highly regulated industries. We are the best choice for companies who are looking for software and service.
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What We Do
With our cloud solutions, market compliance requirements of the Life Science industry can be met quickly and efficiently. Our standardized and proven best practices create individual added value.
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References
Our customers come from various sectors of the pharmaceutical industry. Especially small and medium-sized companies have found the right serialization partner in tracekey.
Read MoreMedTech
29.06.2022 MedTech News
IVDR Preparation – Why is it useful to start now?
The In Vitro Diagnostics Regulation (IVDR) is often mentioned in the same breath as the Medical Device Regulation (MDR). Both regulations came into force on May 25, 2017, and both replace their respective predecessors: the MDR replaces the MDD, while the IVDR replaces the IVDD. A comparison of the regulations is not far off, as […]Read More… from IVDR Preparation – Why is it useful to start now?
Pharma
20.06.2022 Pharma News
Second Source Serialization with tracekey
There are many reasons for marketing authorization holders (MAH) or contract manufacturers (CMO) to inevitably deal with serialization during ongoing operations. May it be to increase production capacity, to connect to a new business partner or any other of many possible reasons. These new conditions can raise some questions. Do I simply increase capacity with […]About tracekey
21.04.2022 About tracekey
The advantages of agile working for pharmaceutical serialization
With the Falsified Medicines Directive (EU FMD), a major digitization project was legally imposed on the entire pharmaceutical industry. From manufacturers, contract packagers, marking systems, and line producers to pharmacies – everyone was involved and had to integrate new processes, systems and hardware into their work within a few years. At the same time, a […]Read More… from The advantages of agile working for pharmaceutical serialization