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

Webpräsenz der Allianz für Cyber-Sicherheit

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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MedTech News 2022
30.01.2023 MedTech News

MedTech News 2022 – The Most Important Developments

Medical devices play a crucial role in modern healthcare. Their regulation is essential to ensure safety and efficacy. In recent years, regulatory changes in this area had a significant impact on industry and patients. In particular, regulatory requirements and changes in and around the Medical Device Regulation (MDR) are compelling stakeholders to stay on top […]

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Trends in Pharma 2022
25.01.2023 Pharma News

Trends in Pharma 2022/2023

The year 2022 was an eventful one for the pharmaceutical industry. Be it the further introduction of track & trace systems around the world, such as Tatmeen in the United Arab Emirates, or the entry of digital health technologies, such as telemedicine, into everyday practice. In this article, we have summarized the most important developments […]

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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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