About Vizera
Vizera is an European clinical research organization (CRO) based in Slovenia (EU) that specialises in clinical trials for medical devices and nutraceuticals. We operate in the Balkan region, mostly in Slovenia, Croatia and Serbia.
Vizera provides:
- Customized clinical research services
- Regulatory services related to obtain the CE mark for medical devices
- Regulatory services referring to obtaining health claims of nutraceutical products or to novel food.
- Registration services for foods for special medical purposes
We guarantee high quality services and results which are delivered on time and within budget.
Services
Clinical Trials
Vizera has a wealth of experience in clinical trials of medical devices and nutraceuticals and provides support with the EFSA claim submission. We also perform clinical trials for pharmaceuticals phase III and IV. We are highly skilled in several therapeutic areas, some of which include diabetes, prediabetes, wounds, gastroenterology, cognitive functions, paediatric health, the immune and cardiovascular systems, urology and gynecology.
Medical Device Regulatory Services
Before a medical device is introduced to the market it must obtain the CE mark. Vizera is experienced in clinical evaluation report preparation as well as complete technical documentation. Vizera also helps you to make the right decisions on how to register your product in the EU in order to avoid incurring additional time and financial costs.
Regulatory Services For Nutraceuticals
Would you like that your nutraceutical product stands out with registered health claim or as a novel food? Vizera prepares the product health claim and novel food application.