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

eIFU
10.04.2025 MedTech News

Electronic Instructions for Use (eIFU) for Medical Devices

Electronic Instructions for Use (eIFU) are digital versions of traditional printed instructions for medical devices. They offer numerous advantages, including improved accessibility and reduced paper consumption. The current situation in the EU, global regulations, and future requirements for medical device manufacturers are discussed in the following article. In Europe, eIFUs have been a topic since […]

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Pharma

barcode history
15.04.2025 Pharma News

The History of the Barcode and Product Serialization

Barcodes and serialization are ubiquitous in our daily lives, yet many of us rarely think about their origins and significance. From grocery stores to pharmacies, these technologies play a crucial role in ensuring efficiency, accuracy, and safety. But what is the history of the barcode? Just over fifty years ago, the shopping process was quite […]

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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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