^

Advice and
Expertise
in Health
and Nutrition
Fields

NUTSEA Consulting is a consulting company and member of the FOVEA Group which specialises in the evaluation of nutritional products in the Health field, bringing together experts in agri-food regulations, toxicologists, evaluation and follow-up study professionals, Key Opinion Leaders (nutritionists, endocrinologists, cardiologists, geriatricians, ...), a network of investigators and a Committee of international experts for the evaluation of the relevance of submissions to the EFSA.

We also assist companies located outside the European Union in importing their products into Europe.

 

Our fields of expertise in Nutrition / health

X

Scientific and Medical Expertise

  • Preparation of technical reports documenting the clinical or physiological benefits of nutritional ingredients
  • Preparation of toxicological reports, examination and toxicological validation of formulas or ingredients
  • Scientific monitoring in response to manufacturers’ requests: literature analysis, preparation of reports on topics of interest in the nutrition/health field
  • Writing of scientific articles
X

Clinical evaluation

  • Study design conception: choosing the study methodology, identifying the population, determining the evaluation criteria, calculating the sample size, developing the statistical methodology
  • Drawing up the protocol and designing the study case report form (e-CRF, e-tools)
  • Regulatory submissions: CCTIRS (Comité consultatif sur le traitement de l’information en matière de recherche dans le domaine de la santé [Advisory Committee on Medical Research Data Processing]), CNIL (Commission nationale de l’informatique et des libertés [National Commission for Information Technology and Civil Liberties]), IRB, ANSM (Agence nationale de sécurité du médicament et des produits de santé [National Agency for Medicines and Health Products Safety]), ...
  • Recruitment of investigators (independent and hospital staff): pre-screening of investigators within our network, conducting the feasibility study
  • Study implementation and follow-up: managing investigator contracts, managing study material, individual or collective initiation visit, monitoring on-site and remote monitoring
  • Data Management, study data analysis, drawing up the study report
  • Designing communication documents (abstract, poster, articles, diaporama, ...)
X

Vigilance

  • Audit and implementation of Nutrivigilance procedures
  • Nutrivigilance management: managing serious cases, from collection to declaration, analysing safety data, drawing up summary reports
X

Advice and support

  • Nutritional audit of products: regulatory status of ingredients, regulatory compliance of labelling
  • Formulation support: choosing ingredients, regulatory status of ingredients, evaluating the safety/toxicity of ingredients
  • Nutritional labelling: advice on the choice of and justification for nutritional and health claims
  • Drawing up health claim application dossiers: analysing available data, recommendations, preparing the application dossier
  • Validation by a committee of international experts of the relevance of submissions to the EFSA
X

Communication

  • Validation of promotional documents (press materials, public information campaigns, ...)
  • Preparation of nutrition/health-related scientific materials for training and/or presentation of nutritional products for medical or pharmaceutical sales representatives and/or management teams
  • Preparation and presentation of nutrition/health-related training materials and recruitment of KOLs in the nutrition/health field
X

Training / Therapeutic Education

  • Developing and delivering training for healthcare professionals (face-to-face and e-learning)
  • Designing therapeutic education programmes (cardiometabolic diseases, obesity, bariatric surgery, young adult nutritional diseases, ...)
  • Therapeutic education training
  • Designing health education materials

WHO ARE WE?

Nutsea Consulting is headed by Doctor Franck Sévenier, a nutritionist who has specialised in Clinical Research and Epidemiology in the Health field for over 20 years.

 

Whatever your need, we will support you at every stage of your products’ life cycle by providing you with the specific knowledge and skills required:

 

  • Nutritional regulation consultants from agri-food industries
  • Opinion leaders in the core therapeutic fields (nutritionists, diabetologists, endocrinologists, cardiologists, geriatricians, ...) whose role is to evaluate the relevance of your studies and ensure the promotion thereof
  • Independent toxicologists specialised in nutritional products
  • Therapeutic education trainers
  • Medical trainers for your sales teams and the promotion of your products to healthcare professionals
  • Network of international experts for the evaluation of the relevance of submissions to the EFSA
  • Network of partners: developer of e-CRF/eTools and connected devices, telemedicine platform, ‘nutrivigilant’ individuals

Our main partners:

  • Telemedicine Technologies
  • Anticip Santé
  • Groupe de Recherche et d’Enseignement sur les Maladies métaboliques et l’Obésité (GRESMO)
  • Fédération Nationale des Associations Médicales de Nutrition (FNAMN)

WHO ARE OUR CLIENTS?

 

 

 

Agri-food industries

 

Health-related industries

 

Medical devices companies

 

Healthcare organisations

 

Learned societies

 

Well-being industries

 

Insurers and mutuals


 

 

 

 

 

CONTACT-US

 

Franck SÉVENIER MD

+ 33 (0) 6 11 40 31 10

3 bis chemin de la Jonchère, F-92500 ~ Rueil-Malmaison

Tél. +33 (0)1 47 14 40 71 • contact@nutseaconsulting.com

 


Name *

Company *

City *

Country *

Phone *

Email *

Message *

* required fields