Vizera helps you make the right decision on how to make a successful launch of your product. Each product category brings different challenges and opportunities.
We are offering regulatory services for the following categories of products:
For medical devices we can support you with:
For medicines we can support you with:
For food supplements and other foods we can support you with:
Would you like your product to stand out in the market with a health claim? We take care of the process of approving the health claim. Claims regarding the beneficial effect of food on health and well-being are governed by Regulation (EC) 1924/2006 on nutrition and health claims made on foods.
Before a new health claim can be put on a product label, it must go through the approval process of the European Food Safety Authority (EFSA).
We assist you in the process of approving health claims on foods.
We provide scientific and technical support to approve a health claim on your product:
If a food is developed with a new structure, innovatively or by using new technologies or production processes, or if it was not traditionally consumed on a significant scale in the EU before 15 May 1997, such food is classified as a novel food and is subject to approval at the EFSA before being placed on the market in accordance with Regulation (EU) 2015/2283 on novel foods.
We help you in the process of approving a novel food.
We offer scientific and technical support for the approval of your product as a novel food: