Food supplements

Novel Food

• Preparation and submission of Novel Food applications 
• Notification of traditional foods from third countries
• Classification as novel or non-novel food
• Gap analysis of existing data
• Research for data substantiating the history of safe food use of the product in the EU prior to 1997 or in countries outside the EU for at least 25 years
• Intake assessments
• Support with the execution of toxicological studies 
• Preparation and execution of counselling interviews with national authorities

Marketability Check

• Country-specific assessment of the marketability as a food ingredient with regards to the demarcation criteria between food, drug, and medical device
• Notification for food supplements and dietetic foods to the responsible national authorities

Health Claims

• Preparation and submission of a health claim dossier to EFSA including:
  o Statements based on new scientific data (Art. 13.5)
  o Statements concerning reduction of a health risk
          (Art. 14)
  o Statements concerning the development of children              (Art. 14)

• Development of a tailor-made health claim strategy and roadmap for your product
• Advice on the possibility to protect proprietary data
• Assessment and evaluation of study protocols with regard to EFSA requirements
• Planning and conduct of EFSA-relevant clinical studies for the scientific substantiation of the health claim

• Verification of marketability and labelling: 
  - Food supplements
  - Foods for special medical purposes (FSMP)
  - Nutritionally incomplete FSMP ("Ergänzende bilanzierte Diäten")

• Development and maintenance of health claims
• Borderline issues related to food supplements, medicinal products, medical devices and cosmetics
• DiapharmKlick: the latest overview of new OTC products in Germany, Austria, Spain, France, the United Kingdom and the US

ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC. 

• RA management from early preclinical stage to the final steps of maintenance of the license
• Dossier compliation and submission
• CMC Program & Project Management
• Investigational Medicinal Product Management
• Scientific Writing