tracekey solutions GmbH
RegTech for Life Science Industry
The better way to stay compliant.
Your business matters – that´s why we help healthcare companies meet global requirements with smart, scalable, and affordable software as well as real-world expertise. Our modern approach enhances compliance: it makes it intuitive, efficient, and aligned with your needs. We believe compliance should be manageable, so innovation doesn´t lose momentum.
MedTech
EUDAMED-UDI compliance made affordable.
Pharma
Global serialization compliance.
Customer References
Made in Europe – We build trust
Situated in Germany, we are committed to ensuring comprehensive clarity in compliance with EU regulations. Our focus on IT security involves implementing robust measures to safeguard sensitive information. Furthermore, this enables us to deliver consistent, high-quality services that meet the evolving needs of both healthcare providers and patients.
- Over 10 years of experience
- In-house support team
- SaaS solutions made in Germany
- European data centers
- GDPR compliant
- Audited by our customers regularly
- Designed and validated in compliance with GAMP&GxP principles
Get to Know Our Solutions
MedTech
mytracekey UDI Manager
Pharma
mytracekey PHARMA
Enjoy peace of mind in regulated environments. We provide ready-to-use software with intuitive interfaces and clear feedback so users feel confident with every action.
Our customer success team is always just one call away. With industry-leading support and a customer-first mindset, we’re here to help you succeed.
Our software ensures compliance with EU-FMD, MDR, DSCSA, and other global regulations – so you can operate seamlessly across borders. We reduce complexity in highly regulated landscapes for you.
Our mytracekey software includes comprehensive validation documentation, audit trails, and more. You’re always prepared for audits and inspections, without additional effort.
tracekey Knowledge Base
Keeping track of worldwide regulations and regulatory topics can feel like a never-ending marathon – we’re running with you! In this space, we are sharing our learnings, regulatory updates, and insights with you. Signing up for our newsletter helps you stay informed and on track.
MedTech
After numerous delays, the first four modules of EUDAMED have now been audited, and their use will become mandatory in six months. This has been confirmed by the publication in the Official Journal of the […]
Pharma
In 2020, the Uzbek government published Decree 737, mandating serialization for tobacco, alcohol, soft drinks, and pharmaceutical products. For medicines, the Central Asian country […]
Other topics
After numerous delays, the first four modules of EUDAMED have now been audited, and their use will become mandatory in six months. This has been confirmed by the publication in the Official Journal of the […]
About tracekey
This year, we celebrated the ten-year anniversary of two employees. Both have been with us almost since the founding of the company in 2013 and have significantly shaped its development. […]