With passion and dedication, our Regulatory Intelligence team constantly analyzes technical issues and national and international regulations, and we actively participate in national and international working groups on standardization.
This is because we want your products – whether they are medical devices, combination product or in-vitro diagnostic – to gain a strong foothold in the market, with well-set activities, timings and costs, and at the same time actively contribute towards making innovative products ready and available to patients and specialists.

Internationality

Internationality

With passion and dedication, our Regulatory Intelligence team constantly analyzes technical issues and national and international regulations, and we actively participate in national and international working groups on standardization.
This is because we want your products – whether they are medical devices, combination product or in-vitro diagnostic – to gain a strong foothold in the market, with well-set activities, timings and costs, and at the same time actively contribute towards making innovative products ready and available to patients and specialists.

Our team is always at your side: backed by a reliable network of established and efficient relationships fostered over the years with European notified bodies, competent authorities and research and clinical institutes, we work together with you for the success of your projects from the preparation and submission of technical and clinical documentation to the revision and auditing by notified bodies, competent authorities or ethical committees, all the way to clinical study approvals and CE marking.

Our team is always at your side: backed by a reliable network of established and efficient relationships fostered over the years with European notified bodies, competent authorities and research and clinical institutes, we work together with you for the success of your projects from the preparation and submission of technical and clinical documentation to the revision and auditing by notified bodies, competent authorities or ethical committees, all the way to clinical study approvals and CE marking.