Foodstuffs and Dietary Supplements
Pharmanager Development supports its clients throughout the entire lifecycle of their products, whether they are foodstuffs and dietary supplements, foods intended for specific groups, or ingredients subject to Novel Food regulations. With our scientific and regulatory expertise, we ensure the proper positioning of your products, the validation of health claims, and their compliance with competent authorities’ requirements. Our services guarantee a safe and compliant market entry..
Claims
We assist you in validating your health claims and ensuring the compliance of your communications. We also help you compile regulatory dossiers to secure their acceptance in the European market and meet the expectations of the competent authorities.
Foods products
We conduct positioning audits to determine the regulatory status of your products and ensure their compliance. Our experts guide you through necessary procedures, including the notifications required for fortified foods in certain EU member states.
Dietary Supplements
We support you at every stage of your dietary supplement development. Through our Phinn® database, we provide fast and reliable access to scientific and regulatory information, ensuring their compliance and success in the market.
Foods for Specific Groups
We help you position your products to determine whether they belong to this category. Our experts assist in building strong scientific dossiers to ensure their compliance and safe market entry.
Novel Food
We guide you through the scientific evaluation and dossier preparation for Novel Food products. Our experts help you meet regulatory requirements to ensure compliance and approval by the competent authorities.
Our answers to your questions
What are the requirements for using a health claim in Europe?
Health claims must comply with Regulation (EU) No. 432/2012, meaning they must be scientifically substantiated and validated by EFSA.
What are the key steps to ensure the compliance of dietary supplements?
These steps include choosing compliant ingredients, verifying claims, validating labels, and registering the product with the competent authorities.
How can you determine if a product falls under foods for specific groups?
This requires a precise evaluation of its characteristics and intended use, as well as verification of regulatory criteria.
What steps are required to register a Novel Food product?
A Novel Food dossier involves an in-depth scientific assessment, including toxicological and nutritional data, followed by submission to the competent authorities for validation.