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: mytacekey HospitalDirect & mytracekey CONNECT

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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USPs of MDM system in comparison with ERP for Medical Technology companies
25.08.2021 News

MedTech: Does Your ERP Cover Everything?

ERP systems offer medical device manufacturers many options for controlling their processes and planning resources. However, they do not cover some use cases such as master data management, as is required in the industry to comply with the MDR. ERP (Enterprise Resource Planning) systems offer numerous possibilities for companies to keep track of figures, data, […]

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UDI Regulation in Saudi Arabia
15.10.2021 FAQs

UDI regulations in Saudi Arabia

The UDI regulations in Saudi Arabia are intended to play a role in health insurance and cost monitoring additionally to increased patient safety. However, the focus is on traceability, market surveillance, and various safety aspects. Authority: Kingdom of Saudi Arabia Food and Drug Administration (SFDA). Timeframe: The SFDA UDI regulation came into force by 01.08.2021. […]

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