{"id":2724,"date":"2025-02-03T10:28:52","date_gmt":"2025-02-03T09:28:52","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?post_type=sector&p=2724"},"modified":"2025-02-03T15:33:17","modified_gmt":"2025-02-03T14:33:17","slug":"regulatory-consulting-specific-food-groups-2","status":"publish","type":"sector","link":"https:\/\/www.pharmanager-development.com\/en\/secteur\/regulatory-consulting-specific-food-groups-2\/","title":{"rendered":"Regulatory and Scientific Consulting for Specific Food Groups \u2013 Compliance & Expertise"},"content":{"rendered":"\n
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Accueil<\/a><\/span><\/span><\/div> <\/div>\n
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Regulatory and scientific consulting for Specific Food Groups<\/span><\/h1>\n

Foods for specific groups (FSG) require careful positioning to ensure compliance with regulations. At Pharmanager Development, we guide you in evaluating and strategically positioning your products to determine if they fall under this category.<\/span><\/p>\n

We also assist in preparing comprehensive scientific dossiers, which include proof of efficacy and product safety. With our expertise, we ensure your products meet both European and national regulatory standards, ensuring a safe market entry.<\/span><\/p>\n \n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n\n\n

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What regulation apply to foods for specific groups?<\/h2>\n <\/div>\n <\/div>\n
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609\/2013<\/strong>\/EU<\/h3>\n <\/div>\n
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This regulation establishes specific rules applicable to foods for specific groups, such as infant formula, meal replacements, and foods for special medical purposes. It harmonizes requirements for composition, labeling, and marketing within the European Union.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n

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Product compliance validation<\/span> <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We analyze your products to ensure they meet the specific regulatory standards for foods for specific groups (FSG), including their composition, formulation, and nutritional characteristics.<\/p>\n <\/div>\n <\/div>\n

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Label Verification <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We ensure that your labels comply with the applicable regulations, including mandatory and optional statements.<\/p>\n <\/div>\n <\/div>\n

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Registration of your products <\/span><\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We manage the declaration process when required, ensuring full compliance with applicable European and national regulations.<\/p>\n <\/div>\n <\/div>\n

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Preparation of Scientific Dossiers <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We compile comprehensive scientific dossiers based on robust scientific data to justify the consistency of your FSMP with the nutritional needs of the target population, to demonstrate the bioavailability of an ingredient usable in FSG, or to build the foundation of your reimbursement application dossier for the LPPR with social security.<\/p>\n <\/div>\n <\/div>\n <\/div>\n \n

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Pharmanager Development assists you in:<\/h2>\n

We support our clients in identifying the most appropriate regulatory positioning by developing positioning strategies tailored to market needs.<\/p>\n

At the same time, we take into account the specific regulatory requirements of each category of Foods for Specific Groups to ensure product compliance from the design stage. We work closely with our clients to guarantee that every step meets the applicable requirements.<\/p>\n

From conception to market placement, we assist you in ensuring the compliance of your products. Our services include verifying compatibility with FSG status, checking composition and labeling, and providing support for product registration with the competent authorities. In doing so, we ensure that your products fully comply with all European regulatory requirements.<\/p>\n \n

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Discover our case studies<\/h2>\n <\/div>\n
\n \n View all case studies<\/span>\n <\/a>\n <\/div>\n \n <\/div>\n
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\n \n <\/span>\n 13 January 2025 <\/span>\n \n Classification and Regulatory Justification of a Medical Food Product<\/a>\n <\/span>\n <\/div>\n <\/div>\n
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\n \n <\/span>\n 13 January 2025 <\/span>\n \n Dietary Supplement Labeling Project: Ensuring Regulatory Complianc<\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n