Expertise
Nutraveris Experts can support you on the following skills area
Foods for Special Medical Purposes (FSMP)
Foods for special medical purposes (FSMP) are intended for the dietary management of patients and may be used only under medical supervision. They are regulated for composition and labeling by Regulation (EU) N° 609/2013 and Regulation (EU) 2016/128 as regards the specific compositional and information requirements for Food for Special Medical Purposes. This Regulation applies instead of Directive 1999/21/EC since 22 February 2019 for FSMP developed to satisfy the nutritional requirements of people other than infants and since 22 February 2020 for FSMP developed to satisfy the nutritional requirements of infants as the delegated Regulation (EU) 2016/127 concerning infant formula and follow-up formula).
These products must be notified at national level and competent Authorities may request a bibliographic dossier justifying that the product meets the specific requirements of the target population.
General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to FSMP.
Novel foods
Scientific serviceTo 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 texts we are working with
Regulatory Compliance
Regulatory serviceTo 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
Scientific serviceDetermine 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.
Regulatory texts we are working with
Food Additives
Scientific serviceEvaluation of the regulatory status of the food additive, within the European Union.
Regulatory texts we are working with
Scientific review / medical writing
Scientific serviceResearch, 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
Regulatory serviceElaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation
Scientific serviceFormulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Clinical study protocol
Scientific serviceWe 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
Regulatory & Scientific servicesThanks 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 & Scientific servicesRegulatory 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
Scientific serviceStrategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)