tracekey solutions GmbH

RegTech for Life Science Industry

The No. 1 for small and mid-sized businesses

In a connected world, the structured exchange of data with international partners and authorities is essential. As a partner of the life science industry, we support you managing digitalization.

Personal. Smart. Agile.

Smart Serialization
Complex requirements of the (pharmaceutical) industry easily implemented


Global Compliance
Agile solutions for international requirements: EU-FMD, DSCSA, Russia, MDR etc.

Digital Twin
One digital duplicate for each product individual – linked into the digitally connected supply chain

Cloud Solutions
Tailor-made modules for your situation: mytracekey HospitalDirect & mytracekey CONNECT

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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Our customers come from various sectors of the pharmaceutical industry. Especially small and medium-sized companies have found the right serialization partner in tracekey.

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05.09.2022 MedTech News

Legacy Devices in the MDR

Legacy devices are not directly mentioned in the MDR but are defined in the Medical Device Coordination Group document MDCG 2021-25. Accordingly, these are medical devices that were placed on the market after the application date of the MDR in 2021 until May 26, 2024, if certain conditions are met. Thus, circa 80% of the […]

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14.09.2022 Pharma News

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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About tracekey

Agile work tracekey +pharma
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 […]

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