Clinical study protocol
NUTRAVERIS is recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health claim or Novel Food authorizations. Following the evaluation of the strengths and weaknesses of the previously performed studies and EFSA opinions, …
NUTRAVERIS is recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health claim or Novel Food authorizations.
Following the evaluation of the strengths and weaknesses of the previously performed studies and EFSA opinions, NUTRAVERIS will design the relevant protocol which takes into consideration EFSA requested criteria for the evaluation of applications for authorization of health claims made on foods, including:
- Specific procedures for human intervention studies (adequate control group, full randomization, treatment allocation concealed, power/ sample size calculation…)
- Appropriate dose for the recommended conditions of use (according to the labeling or project of labeling)
- Relevance of inclusion/non-inclusion criteria for the study population in view of the target population for which the claim is intended
- Biological and analytic validity of the surrogate markers of the claimed effect
- Relevance of the main criteria of efficacy in view of the wording of the target claim
- Adequacy of the intervention’s duration in view of the recommended conditions of use and the claimed effect
- The scientific background relative to the study
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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)