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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UDI Unterschiede in EU & US
01.08.2022 MedTech News

UDI Differences – Comparison between US and EU

On September 24, 2013, a directive was passed in the United States to introduce an identification system for MedTech products, which came into force on December 23 of the same year. It comes in the form of the Unique Device Identifier (UDI) and is intended to simplify the tracking of medical devices sold in the […]

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Cloud und IT Sicherheit
07.07.2022 Pharma News

Cloud and cybersecurity in pharma

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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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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