The Vizera team manages clinical trials for medical devices and nutraceuticals (food supplements, functional food and food for special medical purposes). We also perform clinical trials for pharmaceuticals phase III and IV.
Our carefully selected and well-trained staff have extensive experience in the design and implementation of a wide range of clinical trials in all major therapeutic areas, with particular expertise in the following fields:
We have established a strong and wide-reaching network of investigator and clinical sites in the Balkan region, specifically in Slovenia, Croatia and Serbia.
In order to demonstrate the safety and efficacy of your product our team offers the following services for the conduct of clinical trial:
In order to demonstrate the safety and/or efficacy of your product, our team offers the following services for the implementation of clinical trial:
Communications regarding the health benefits of food products in the European Union are regulated by the EC directive 1924/2006. The EU Commission must approve any health claims before they may be used in the wording of the label.
Vizera provides scientific and technical support in order to obtain approval for your product’s health claims:
If the food is newly developed, innovative food, food produced using new technologies and production processes, or it is / has been traditionally eaten outside of the EU it is considered as a novel food and must be authorized by the EFSA (Novel Food Regulation (EU) 2015/2283). Vizera performs scientific and technical services in order for your product to be authorized as a novel food:
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.
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.