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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Post Market Surveillance Costs
26.07.2023 MedTech News

Post-Market Surveillance and its Costs

Even with intensively tested medical devices, unknown side effects can occur among users. If such an incident does occur, it must be documented according to Article 80(2) of the Medical Device Regulation (MDR). The EUDAMED database is the contact point for this respective documentation. In addition, there is a reporting obligation for incidents that have […]

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Food Supplements Russia
27.09.2023 Pharma News

Food Supplements – Serialization in Russia

Chestny ZNAK is the track andtrace system for the Russian market. Apart from pharmaceuticals, it ensures the security of the supply chain of many other goods. These goods include tobacco products, beer, medical devices, and food supplements. Counterfeit protection is expanding to fields other than pharmaceuticals, as Russia’s markets are particularly affected by counterfeiting. According […]

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About tracekey

Many babys were born at tracekey in 2022 and 2023.
29.09.2023 About tracekey

Baby Boom at tracekey: Seven Babies in 16 Months

tracekey is not a big company, but with its number of employees clearly belongs to the SMEs. Many staff absences at once can therefore have a much more noticeable impact than in larger companies. And yet our managing directors and everyone else managed to stay completely relaxed when “We’re having a baby” suddenly became a […]

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