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.

Read More

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.

Read More

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.

Read More

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.

Read More

MedTech

EUDAMED Solution
10.12.2024 MedTech News

Challenges of the MDR – Our EUDAMED Solution

Despite some delays, the final EUDAMED deadline is not far off. Its scope remains challenging for manufacturers. The requirements of the Medical Device Regulation (MDR) are overwhelming, there are not enough capacities in the company, and the budget is also tight. At the same time, there is uncertainty about further potential changes to the MDR. […]

Read More… from Challenges of the MDR – Our EUDAMED Solution

Pharma

Pharma Serialization Provider Switch
07.01.2025 Pharma News

Serialization Provider Switch to tracekey with a Tight Schedule

Success Story: Serialization Provider Switch | Mensana (MAH) faced the challenge of switching serialization providers to tracekey solutions. Thanks to our proven transition concept and experienced Customer Success Team, the transition was accomplished smoothly without production downtime. This article explains how it was done and what aspects helped. The switch of Mensana from another L4 […]

Read More… from Serialization Provider Switch to tracekey with a Tight Schedule

About tracekey

End of the year review: The picture shows a golden 2024 on orange background
14.01.2025 About tracekey

2024 Year in Review: UDI Manager and Best Practices

We look back on a year of great leaps: Especially in the area of our MedTech solutions, an incredible amount has happened. In addition to numerous improvements to our software, we were also able to support our customers with our newsletter, the integration of new markets, and the implementation of new regulations. Let´s recap 2024: […]

Read More… from 2024 Year in Review: UDI Manager and Best Practices

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 […]

Read More… from The New Battery Law and the Digital Product Passport