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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References

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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Career

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

M2M-Schnittstelle zur EUDAMED; M2M Connection to EUDAMED
11.03.2025 MedTech News

The M2M Interface to EUDAMED: A Technical Advantage

The direct connection to EUDAMED, M2M, has numerous advantages. While the initial setup may be somewhat complex, it becomes manageable with a competent and experienced software partner like tracekey. The M2M interface to EUDAMED (Machine-to-Machine) enables the direct and automated exchange of information between internal systems, such as the mytracekey UDI Manager software and the […]

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Pharma

tracekey customer support
13.03.2025 Pharma News

Above and Beyond: tracekeys’ Customer Support

One of the core competencies of a SaaS solution provider is, of course, customer support. Typically, standard support includes providing technical assistance, help with onboarding, as well as configuring and using the software solution. If the customer encounters issues, support rushes in to offer solution-oriented assistance. For many providers, customer support ends at this point. […]

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About tracekey

Zusammenarbeit/Joint work
18.03.2025 About tracekey

Interdisciplinary Collaboration at tracekey

At tracekey, all departments are interconnected and work together towards many goals. Our workflows not only involve daily exchanges within our teams about current developments. In various configurations and meetings, all teams keep each other updated on the status of software development, new market developments, customer requests, and current marketing campaigns. None of our departments […]

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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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