Overview

A nutraceutical product is classified as a dietary supplement in one country and the same product is recognized as a food for special medical purpose by the Health Authority (HA) of another country. In such scenarios, company cannot afford the mistake of misinterpretation. Whether it is to decode dossier requirement, claims, prohibited list of ingredients or import regulations for their nutraceutical products, a company must be aware of all the necessary requirements.

Freyr with an exclusive focus on providing Regulatory Intelligence(RI) solution for nutraceutical/food & dietary supplement category, assists companies from addressing any focused Regulatory query, overview of any country’s regulations or requirement to assess the Regulatory needs for product registration. Freyr offers customized and reader friendly Regulatory report addressing the major topics a device company must know before entering any market.

 

Freyr Expertise

  • Regulatory overview of country
  • Product categorization & classification
  • Registration/notification requirements
  • Registration requirements
  • Labeling & packaging requirements
  • Ingredient analysis & limits
  • Claims
  • Advertising
  • Clinical study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirement
  • Post-marketing surveillance 
 

Freyr Advantages

  • Skilled and experienced Regulatory professionals
  • Proven expertise in:
    • Regulatory analysis and assessment
    • Regulatory report writing
    • Regulatory secondary research
    • Regulatory primary research