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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Clinical Evaluation for Medical Devices
22.03.2023 MedTech News

Clinical Evaluation of Medical Devices

Many manufacturers ask themselves whether a clinical evaluation or clinical trial is necessary for their medical devices. The MDR requirements are quite extensive and specific. Various products previously categorized as equivalent under the MDD now belong to a different risk class and existing clinical data are often no longer accepted by notified bodies. The MDR […]

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Artificial Intelligence in Pharma
13.03.2023 Pharma News

Artificial Intelligence in the Pharmaceutical Industry

Artificial intelligence (AI) is a broad field of computer science that deals with the development of intelligent machines. These can perform tasks that usually require human intelligence, such as visual perception, speech recognition, decision-making, and language translation. AI within this context involves the development of algorithms and computer programs that enable machines to learn from […]

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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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