Is your product clinically effective and regulatory supported for successful launch?

#ClinicallyProven #RegulatorySupported #MarketAccessible

Vizera is a European clinical research organization (CRO) based in Slovenia (EU) that specialises in clinical trials for medical devices, medicines and nutraceuticals. We operate in the Balkan region, mostly in Slovenia, Croatia and Serbia.

We are a group of professionals with the capability and expertise to design and implement clinical trials. Our carefully selected and trained staff master the art of managing clinical trials in all major therapeutic areas. 

A broad network of key opinion leaders, specialists, physicians and scientists in place assures that the wealth of knowledge and proficiency at Vizera’s disposal leads to optimum results.

With our wide comprehension of EU and local legislation we also provide regulatory services for medical devices, medicines and nutraceuticals.

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We provide:

Customized clinical trial services

  • Medical devices 
  • Medicines 
  • Food supplements and other nutraceuticals

Regulatory services

  • Medical devices
  • Medicines
  • Food supplements and other nutraceuticals
  • Health claims
  • Novel food
Clinical trials

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.

Research and development

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.