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

Website of the Alliance for Cyber Security

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 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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Would you like to become part of our agile team? Then take a look at our careers page to find out what you can expect from tracekey and what vacancies we currently have.

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EUDAMED User Guides
06.06.2024 MedTech News

Overview of the EUDAMED User Guides

EUDAMED stands for European Database on Medical Devices. It was introduced as part of the Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR). Manufacturers register their products here and store all relevant data such as certificates and studies. Thanks to this database, patients can easily access information about the medical […]

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13.06.2024 Pharma News

Aggregation in the Pharma Industry

Products, as we buy them in the store, are usually available in cardboard boxes, plastic film, cans, or bottles. Here we are talking about primary packaging. It is the packaging that directly surrounds the product. For easier transportation, primary packaging is combined in larger packaging, for example in a wine crate. This level is called […]

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About tracekey

Customer Satisfaction 2023/24, Kundenzufriedenheit 2023/24
18.06.2024 About tracekey

Customer Satisfaction Survey for the Year 2023/24

In our tenth anniversary year of 2023, we consistently received positive feedback from our customers, both long-standing and new. They rated us an average of 4.9 out of 5 for satisfaction and the likelihood of recommending our services. Our customer support also received high praise. “Your solution-oriented work is top.” “On a human level, it […]

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Further topics

battery law and digital product passport
04.12.2023 Other

The New Battery Law and the Digital Product Passport

The extraction and processing of raw materials is responsible for half of all greenhouse gases globally. These are necessary for the linear model of our economy that has been established for decades. Earth’s resources are extracted, processed into products, and soon afterward discarded. As a result, a significant amount of resources is simply lost. Improving these […]

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