Overview

Based on the classification and product type, health food products may vary in different countries. For instance, in some countries, food products may be categorized as low-risk, medium-risk and high-risk foods, while in other countries, they could be categorized under the ‘food for listed’ category or the ‘food for registration’ category, or as ‘food for special use’ or ‘food for medicinal use’. Hence, the required technical documents also vary. Few examples of technical documents required are documents for:

  • unit formula and batch formula
  • manufacturing process
  • control procedure for active and inactive raw materials including the certificate of analysis of active ingredient(s) with its specifications
  • control procedure for finished products
  • storage condition of the finished product and its predicted expiry date
  • stability study
  • packaging materials (food grade certificate)
  • labeling parameters required for labeling unit carton, inner labels and blister/strips, etc.

At Freyr, we provide various services to cater to your technical documents/dossier compilation requirements. These include compilation of the documents required for registration/notification, reviewing the documents as per Health Authority (HA) requirements, providing support while preparing the   documents and suggesting any additional mandatory documents required by the concerned HA. 

 

Freyr Expertise

  • Registration/notification documents compilation
  • Reviewing documents as per Health Authority (HA) requirements
  • Support for document preparation
  • Suggesting additional mandatory documents
 

Freyr Advantages

  • Cost-effective
  • End-to-end Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, nutraceuticals, health functional foods (HFF), health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with different HAs
  • Structured approach to ensure quick market access