Regulatory Compliance Audit and Notification

This service is part of our Scientific and Regulatory Expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : Novel Food consulting evaluation, Regulatory Compliance & notification, Health Claims, …

You have developed a dietary supplement

You have developed a supplement that stimulates immunity thanks to Echinacea, decreases stress with magnesium, enhances sleep quality thanks to melatonine, prepare skin to suntan with beta-carotene, body to muscle mass growth with BCAA , or designed the best slimming in the form of gummies? It is now time to put it on the market, but before that, there is a essential regulatory step to take: check the regulatory compliance of your food supplement with the European and national rules and texts in place for each the countries where you will sell them.

We take care all of this stages of regulatory compliance

We are specialist in formula analysis, labeling compliance and (mandatory) notification of your product in the countries where it is marketed.

We cover the following steps

1. Regulatory audit and adjustment

   We analyze the regulatory status of active ingredients, additives and verify the dosages.

2. Rules of labeling

   We review all mandatory information and also add specific warning due to single ingredients used

3. Analyze of the communication

   We review all the nutritional and health claim usable on your labeling and marketing tools

4. Validation of label compliance

5. Product notification in sold countries

   We will prepare and submit of files for notification in the targeted countries in accordance with local regulations, with prior registration in other countries if necessary, to enable mutual recognition process. We will ensure the follow-up until authorization and will send you the proof of filing or notification or a notification certificate

6. Transmission of an authorization proof