Expertise
Nutraveris Experts can support you on the following skills area
Food Supplements
Food supplements, considered foodstuffs, are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dosage forms designed to be taken in measured small unit quantities.
Directive 2002/46/EC establishes the specific provisions on the labeling of food supplements and lists vitamins and minerals (and their forms) authorized in food supplements. However, maximum amounts of those vitamins and minerals and the use of substances with a nutritional or physiological effect of which botanicals are not harmonized at European level. For formulation of a food supplement, the national specific legislations as amended on authorized ingredients and possible maximal daily doses have to be checked.
General food law (food safety, information to consumers, novel foods, nutrition and health claims…) also applies to food supplements.
Each Member State has established its own notification or registration procedure which is mandatory before placing a food supplement on the market no matter what is your channel of distribution (pharmacy, online…).

Novel foods

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.

Regulatory Compliance

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
- Austria
- Belgium
- Bulgaria
- Croatia
- cyprus
- Czech Republic
- Denmark
- Estonia
- Europe
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Monaco
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
Health Claims

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.

Food Additives

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.
Quality

Elaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation

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
Training

Thanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized training sessions in Nutrition and Health
Due Diligence

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 survey

Strategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)