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

Medical Devices National Databases
10.04.2024 MedTech News

National Databases for Medical Devices

Before the 2017 adoption of the Medical Device Regulation (MDR) and thus EUDAMED, there were already national databases for medical devices in the EU countries. As in many aspects of the economy, the European medical device market was highly fragmented before the introduction of the MDR. Therefore, it was and is difficult for manufacturers to […]

Read More… from National Databases for Medical Devices

Pharma

Verantwortug/Obligations der MAH (Alert Management)
02.04.2024 Pharma News

Alert management in the EU-FMD: responsibility of the MAH

With the go-live of the EU-FMD and the first scans in pharmacies, high numbers of error messages did arrive. Analyzing these alerts and reporting them back to the EMVO is the responsibility of the pharmaceutical manufacturers (MAH) and the national authorities. However, for a long time, the authorities and the MAHs ignored the error reports. […]

Read More… from Alert management in the EU-FMD: responsibility of the MAH

About tracekey

15.02.2024 About tracekey

The importance of diverse teams at tracekey

Diversity is one of the buzzwords that companies use to attract new talent. The idea behind this word – an open-minded company where every person can find their place. This sounds attractive to many people and management magazines also consider diverse teams to be more productive and successful. Of course, diverse teams are somewhat more […]

Read More… from The importance of diverse teams at tracekey

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