Service in details
Evaluation of the regulatory status of the food additive, within the European Union (regulations 1333/2008).
Scientific pre-diagnosis of the data, in accordance with regulatory requirements of admissibility
- Analysis of additive characterization data and analytical methods
- Exposure Calculation
- Analysis of the pharmacokinetic and stability data of the additive
- Analysis of safety/toxicity and allergenicity studies on the additive
Recommendations from our experts
- Strengths and weaknesses of the rationale
- Additional information to be provided, including any toxicological and/or quality studies to be carried out.
Constitution & submission of the dossier
- Constitution of the request for authorization
- Submission to the European Commission
Follow-up & exchanges with the authorities (EFSA, European Commission).
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Dedicated Physiology & Toxicology PhD experts
The best expertise on the market
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)
Due diligences
- 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
Formulation
Formulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
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Thanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized custom made training sessions
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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
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