ProductEx_0.png
Product Expertise
Understanding the science behind your product
Orphan drugs, biologics, or implantable devices present completely different challenges.
Our work is led by product specialists, experienced in bringing to the market the type of
product that our clients are developing.
Nutritionals and Nutraceuticals describe the product category occupying the regulatory border between food and drug products, and include dietary/food supplements like vitamins, minerals and herbal supplements; probiotics, prebiotics and synbiotics; medical foods and food with health claims. These products are generally purchased over-the-counter (OTC) and typically consumed for the benefit of health maintenance and wellbeing, or may be recommended by health practitioners for the dietary management of disease conditions. Read More

VCLS Solutions

Science-based, global product development strategy and planning

  • Identify registration path and pertinent regulatory requirements
  • Define optimal regulatory strategy for successful international market entry taking into consideration potential different regulatory requirements depending on targeted local markets
  • Ensure compliant strategies for labeling and promotion materials
  • Prepare and submit notification/registration dossiers in key global markets
  • Conduct vigilance reporting
Novel food and novel food ingredient

  • Justify non-novel food or food ingredient classification
  • Construct appropriate regulatory dossier
  • Perform gap-analysis
  • Review regulatory dossier
Non Clinical and Clinical Development

  • Define appropriate clinical development program
  • Correct definition of study population and clinical end-points
  • Assist with protocol design for animal and human studies
Nutrition and Health Claims

  • Determine appropriate nutrition and health claims development strategies
  • Develop pertinent product claim dossier
  • Prepare international dossier submission and representation with the authorities