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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UDI Anvisa Brazil
26.11.2021 MedTech News

UDI Resolution in Brazil: What needs to be considered?

At the beginning of 2021, Brazil started to finally implement its UDI regulations. This is being done in stages with the involvement of various stakeholders. As with pharmaceuticals, Anvisa is the responsible authority. It is responsible for enacting the appropriate legislation, it reviews approvals for medical devices, and it monitors manufacturers’ quality management systems to […]

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EMVO AMS, Alert Management for Pharma
20.12.2021 Pharma News

What is the advantage of active alert management for me as a pharmaceutical company?

Alert Management & EMVO AMS | Alerts keep the industry busy – ever since the start of the active commissioning of the serialization activity. The system, which is supposed to protect patients from counterfeit medicines, produces many error messages from the very beginning when verifying medicines in the pharmacy. These are almost exclusively false positive […]

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About tracekey

Kundenzufriedenheit/customer satisfaction
29.01.2021 About tracekey

Customer Satisfaction 2020 at tracekey

Through daily contact with our customers, we know in most cases which topics are currently important, whether certain features have priority or how satisfied our customers are with us overall. Nevertheless, it is important to ask further questions regularly. We did so in the 2020 retrospective, and give a brief overview here for our customer […]

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