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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MedTech in UK
06.05.2024 MedTech News

MedTech Regulations and MDR in the UK

On December 31, 2020, the Brexit transition phase ended, along with the validity of EU regulations in the UK. Since leaving the EU, the United Kingdom (UK) has been struggling with corresponding hurdles. There is a shortage of workers in some sectors, sales to the EU have decreased, and there have been significant costs associated […]

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Best Practice für EU FMD / Best Practice for EU FMD
13.05.2024 Pharma News

Best Practice EU FMD: Our Learnings

The European Falsified Medicines Directive (EU FMD) came into force on February 9, 2019. For many pharmaceutical companies, this was the first step towards serialization and often required a rapid introduction of digital processes. The situation was different in Italy, Greece, and Belgium. Systems for verifying and tracing medicinal products have been in place here for some […]

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About tracekey

Scrum at tracekey solutions. A week in the life of our scrum master/Eine Woche im Leben unserer Scrum Masterin.
30.04.2024 About tracekey

One Week in the Life of our Scrum Master

Time doesn’t usually pass by that quickly for our Scrum Master, Friederike Ehmer. In this article, we’ll accompany her during five key meetings, and take a closer look at her day-to-day work and collaboration at tracekey. But first, let’s start with general information about agile practices and Scrum. When tracekey was founded in 2013, 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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