Scientific and Regulatory Training in Nutrition and Health
Thanks to its certification as a professional training organization (trainings which are reimbursed by the government in France), scientific and regulatory experts from Nutraveris offers you personalized custom made training sessions, in our office or in yours, depending on your …
Thanks to its certification as a professional training organization (trainings which are reimbursed by the government in France), scientific and regulatory experts from Nutraveris offers you personalized custom made training sessions, in our office or in yours, depending on your needs, in the following areas:
European / national regulatory framework and their evolution:
- Food supplements
- Sports nutrition
- Food for Special Medical Purposes (FSMP)
- Infant nutrition
- Meal replacements
- Fortified foods
- Novel food
Legal status of formulations (authorized ingredients, maximum doses, warnings, mutual recognition), of labeling rules, procedures of notification or registration.
Communication (labels, sales material/leaflets/brochures, instructions, web and advertising on sell location): scientifically and legally acceptable claims in the field of the Regulation 1924/2006 about nutrition and health claims, taking into account the importance of knowing the limits which could lead to a requalification to a drug by presentation or a judgment for misleading advertisement.
Regulation 1924/2006 about nutritional and health claims: interpret the European community’s text, procedure and imposition, deadlines, files constitution, prerequisites, analysis of authorities’ opinions and explanations of the reasons, how to be compliant with the regulation and law penalties.
Nutrition and dietetic basis: structures, roles, sources and needs in macronutrients, vitamins, minerals, functional ingredients (CoQ10…).
Being conversant with principal ingredients by application: Indications of the major dietary supplement market segments (energy, weight management, joints, skin, stress/sleep, vision, urinary comfort…) and explanation of the principal health benefits and issues with physiological (not pharmacological) improvement targets by key ingredients.
Studies and efficacy/safety files: requirements and prerequisites, file’s typology, necessary studies in the context of the regulation about claims and nutrivigilance.
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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)