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

AI Act Medical Devices
26.08.2024 MedTech News

AI Act – Impact on Medical Devices

The European Union’s AI Act is a comprehensive regulation establishing a legal framework for artificial intelligence (AI) for the first time. The law was passed on May 21, 2024, and came into force on August 1 of the same year. It regulates the development, deployment, and use of AIs. The aim is to improve the […]

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Pharma

Serialization in Vietnam
11.09.2024 Pharma News

Serialization in Vietnam

The Vietnamese pharmaceutical market has recently experienced strong growth. According to current forecasts, the market is expected to reach a turnover of around USD 2.4 billion in 2024. Furthermore, an average annual growth rate of 4.25 % is expected until 2029. Growth will be boosted by factors such as an ageing population, rising healthcare expenditure […]

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About tracekey

IT Ops
25.07.2024 About tracekey

IT Operations: without them nothing works at tracekey

IT Operations is at the heart of tracekey. Just as the People and Culture Team contributes a certain feel-good factor at tracekey and takes care of all administrative HR activities, IT-Ops ensures that everything runs smoothly in the IT area. Without them, nobody would have a working laptop, there would be no intranet and our […]

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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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