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.
EU & USA Regulatory Compliance & Notification
- Compliance analysis & adjustments of composition, rules of labelling, communications
- Label validation
- File development & submission to national authorities (EU only)
- Follow up & exchange through authorization
- Experts & artificial intelligence solutions
- The largest practice in the market (more than 4000 products authorized)
- Regulatory compliance (Formulation, claims..)
- Scientific support compliance (efficacy, interactions, safety...)
- Quality insurance evaluation (process, controls, analysis...)
- Export feasibility in other countries
- Strategic recommendations
- Experts in all these areas of expertise
- Regular practice for investment funds and on most recent deals