RegTech for Life Science Industry

Enabling Digital Market Compliance since 2013

In a connected world, global product safety initiatives are becoming increasingly important. They also pose new and complex challenges to players already operating in highly regulated markets. As a result, companies need reliable and agile partners to help them find answers to ever more diverse requirements. Our holistic focus not only includes efficient and modern SaaS solutions but also lies above all in the needs of our customers.

As a RegTech company for Life Science, we help our customers to meet regulatory requirements on a global scale. We connect manufacturers, producers, contract manufacturers, government agencies, and other platforms that benefit from our many years of experience as a digitalization partner for SMEs. Our cloud services are therefore process-oriented and solve the problems of the manufacturing industry.

Our cornerstones


  • Experience: We have years of experience with highly regulated industries
  • Specialization: As a partner to the life science industry, we support SMEs in digitalization
  • Technology: We are not only good at software, but also at service. We are one of the leading gateway providers for the traceability of medicines and networking of production, business partners, and authorities.

We don’t just sell a software; we offer what our customers need

For us, software solutions and support go hand in hand and create added value in the cooperation with our customers and the joint further development of our solutions. With our mytracekey solutions, we take a holistic approach. From the first discussion to the development of complementary solutions to our serialization software – our customers and their needs are our priority: individual contract design, fair and transparent pricing, and modular software that we continue to develop in collaboration. We base the further development of our software solutions and services not only on current regulations but above all on the needs of our customers. This includes, among other things, personal service, support, and the consideration of customer wishes when expanding our service portfolio. To this end, we are in constant contact with our customers. Small and medium-sized companies in particular benefit from this. For them, we also develop niche solutions that significantly simplify their day-to-day operations but are not profitable for larger solution providers.

Our SaaS solutions

Our service is based on providing scalable cloud solutions for the life science industry. Also, we focus primarily on collaboration with our customers. Our solutions simplify and improve their processes and contribute to their business success. With us, support does not stop after onboarding, on the contrary. We accompany our customers as partners throughout the entire business relationship. In doing so, we always maintain close contact with the companies and can thus react to individual needs and align our software solutions accordingly.

Besides, we work with the latest technologies and security standards. This means using a modern and flexible system architecture, which allows us to develop our software in the long term, easily and cost-inexpensively. Not only do we offer our customers software that meets the latest market compliance requirements, but it also provides standardized ways to communicate and network with your business partners and other systems. Our modular SaaS solutions consider the individual needs of our customers, enabling added value beyond digitalization.

Cloud services at a glance


  • mytracekey PHARMA – Do you want more than just serialization software? We have a full-service serialization solution for the pharmaceutical industry.
  • mytracekey ALERTS – Processing EMVO alerts cost you a lot of time? We have developed a solution for this in short, which makes your work easier through our Alert Management Service.
  • mytracekey HospitalDirect – Do you supply hospital pharmacies and would like to offer consolidated shipment data deliveries? We have developed a corresponding service for easy serial number transport to your hospital customers.
  • mytracekey MedTech – Do you have to comply with the MDR? Use our SaaS solution for medical devices for distributors and manufacturers.
  • Level 3 automation – Do you want everything from one source? Take a look at our joint offer with our partners.

Your contact persons

Vanessa Brenne Vice President Europe tracekey solutions
Vanessa Brenne
VP Sales Europe
brenne@tracekey.com

Li Jasmin Song
VP Sales APAC
song@tracekey.com
Shashank Shekhar
VP India & Middle East
shekhar@tracekey.com
Any questions? Are you interested? Let us know!

 

Read more on our blog: How do the term RegTech and the Life Science industry fit together?