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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7 Tipps für die Datenpflege
12.05.2022 MedTech News

7 Tips for Data Preperation in EUDAMED

The European Commission regularly publishes documents to assist in the use of EUDAMED. Due to the complexity of EUDAMED as well as the multitude of instructional documents, it is nevertheless important to get an overview yourself. This way you will learn which aspects apply to your own company and your products. It is the only […]

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Case Study: CMO Stegemann + 3 Level provider Mettler Toledo
16.03.2022 Pharma News

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