EU & USA regulatory Compliance & Notification
Product notification is, in most of the EU countries, mandatory before a product is placed on the market. It must be made per product and in each country of final marketing. Each country has its own regulations and procedures and its own deadlines for evaluation and validation
You have developed a food supplement
You have developed a food 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
Nutraveris is a specialist in formula analysis, labelling compliance and (mandatory) notification of your product in the countries where it is marketed.
We cover the following steps
- Regulatory audit and adjustment
We analyze the regulatory status of active ingredients, additives and verify the dosages.
- Rules of labeling
We review all mandatory information and also add specific warning due to single ingredients used
- Analyze of the communication
We review all the nutritional and health claim usable on your labeling and marketing tools
- Validation of label compliance
- 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
- Transmission of an authorization proof
The biggest practice in the market (more than 5000 products authorized)
- Czech Republic
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To evaluate the regulatory status of the native ingredient before processing.
Procedure selection, Scientific gap analysis of the data in accordance with Regulatory admissibility criteria, Recommandations, File constitution & submission.
To declare the placing on the market of your food supplements to the national authorities.
Formula analysis, labeling compliance and notification of your product for Europe and USA
- Czech Republic
Determine whether you need a specific claim and if so, prepare and submit the claim file.
Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria, reccommendations of our experts, file constitution and submission.
Evaluation of the regulatory status of the food additive, within the European Union.
Scientific review / medical writing
Research, analysis and synthesis of all data related to the efficacy/ physiological effect/safety of ingredients when taken orally, according to existing scientific literature published in peer reviewed journals and according to regulatory requirement in force.
Elaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Clinical study protocol
We are recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health Claim or Novel Food authorizations
Thanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized training sessions in Nutrition and Health
Regulatory compliance review (Formulation, claims..), Scientific support compliance (efficacy, interactions, safety…), Quality insurance evaluation (process, controls, analysis…), Export feasibility in other countries, Strategic recommendations
Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)