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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Software as a Medical Device
09.01.2024 MedTech News

Software as a Medical Device

Software as a Medical Device (SaMD) is a collective term for software used for medical purposes. SaMDs exist as stand-alone products and as parts of other medical devices. Their legal definition varies from country to country. For example, the Medical Device Regulation (MDR) defines them as follows: Software intended to be used alone or in […]

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21.02.2024 Pharma News

Italy: From Bollino to EU-FMD

On February 9, 2025, the last three EU member states will introduce the European pharmaceutical serialization system. The European Falsified Medicines Directive (EU-FMD) came into force on February 9, 2019. However, Italy, Belgium, and Greece were granted a six-year exemption, as these countries already had existing systems for verifying and tracing medicinal products. In Italy, […]

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About tracekey

15.02.2024 About tracekey

The importance of diverse teams at tracekey

Diversity is one of the buzzwords that companies use to attract new talent. The idea behind this word – an open-minded company where every person can find their place. This sounds attractive to many people and management magazines also consider diverse teams to be more productive and successful. Of course, diverse teams are somewhat more […]

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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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