Based on the classification and product type, food supplement/nutraceutical product compliance requirements may vary from country to country. 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 documents as per Health Authority (HA) requirements, providing support while preparing the documents and suggesting any additional information for food supplement/nutraceutical safety report documentation required by the concerned HA.
- Registration/notification document compilation
- Reviewing documents as per Health Authority (HA) requirements
- Support for food supplement/nutraceutical safety report documentation
- Suggesting additional mandatory documents
- Food supplement/nutraceutical product compliance
- Cost-effective Regulatory solutions
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of health foods like health supplements, dietary supplements, food 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
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