At DEMOS GLOBAL GROUP, we offer a specialized regulatory consulting service for the FDA, designed to simplify the regulatory compliance process as much as possible.<\/p>\n
We know that every company and every product has unique characteristics. That’s why our team conducts a personalized analysis of your situation, identifies the applicable requirements, and develops a detailed action plan to obtain your FDA registration without any setbacks.<\/p>\n
We take care of reviewing labels, ingredients, technical documentation, laboratory reports, good manufacturing practice (GMP) manuals, and all the procedures required by the US authorities.<\/p>\n
Thanks to our experience and network of authorized agents in the US, we guarantee that the entire process is carried out safely, quickly, and transparently, in compliance with the laws in force for each product category.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
FDA compliance according to your product type<\/span><\/h2><\/div>FDA compliance according to your product type<\/span><\/h2><\/div><\/div><\/div>Comply with FSMA legislation and guarantee the food safety of your products<\/span><\/h2><\/div>Comply with FSMA legislation and guarantee the food safety of your products<\/span><\/h2><\/div>At DEMOS GLOBAL GROUP, we specialize in the Food Safety Modernization Act (FSMA) regulations, one of the most important laws passed by the FDA to ensure the safety of food consumed in the United States.<\/p>\n<\/div><\/div><\/div>
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Regulatory compliance with the FSMA Act.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Verification of product labeling and presentation.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Registration of food facilities with the FDA.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>- <\/i><\/span>
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Management of new or modified ingredients.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Control of additives, colorants, and substances in contact with food.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Prior notifications and tracking of international shipments.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>Comply with quality standards and avoid border rejections<\/span><\/h2><\/div>Comply with quality standards and avoid border rejections<\/span><\/h2><\/div>Dietary supplements are one of the fastest-growing sectors in the United States, but also one of the most tightly regulated. The FDA requires exporting companies to adhere to strict quality and traceability standards to ensure consumer safety.<\/p>\n<\/div><\/div><\/div>
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Registration of companies with the FDA and authorized agent.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Review of labels, ingredients, and property declarations.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>- <\/i><\/span>
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Classification of the product according to its regulatory category.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Procedures for notification of sale and intention to market.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>Register your cosmetic products and over-the-counter drugs in accordance with FDA guidelines.<\/span><\/h2><\/div>Register your cosmetic products and over-the-counter drugs in accordance with FDA guidelines.<\/span><\/h2><\/div>Cosmetic products and OTC (Over The Counter) medications must comply with a series of regulations established by the FDA in order to be marketed in the United States. These standards cover aspects such as company registration, ingredient safety, labeling, and good manufacturing practices.<\/p>\n<\/div><\/div><\/div>
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Registration of manufacturers with the FDA.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Review and verification of labels.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Classification of products between cosmetic and OTC.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>- <\/i><\/span>
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Product registration and obtaining the NDC.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Preparation of GMP manuals and SOPs.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Verification of permitted ingredients and restrictions.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>Complies with FDA quality and safety standards for medical devices<\/span><\/h2><\/div>Complies with FDA quality and safety standards for medical devices<\/span><\/h2><\/div>Medical equipment and devices are subject to comprehensive regulation by the FDA, which ensures their effectiveness and safety before they are distributed or used in the United States.<\/p>\n<\/div><\/div><\/div>
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Registration of company and US agent with the FDA.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Clasificaci\u00f3n de dispositivos m\u00e9dicos (Clase I, II o III).<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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510K and PMA registrations.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div>- <\/i><\/span>
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Technical advice on documentation, testing, and validation.<\/span><\/p>\n<\/div><\/li>- <\/i><\/span>
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Review of manufacturing processes and GMP compliance.<\/span><\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>Your expert partner in FDA regulation and international export<\/span><\/h2><\/div>Your expert partner in FDA regulation and international export<\/span><\/h2><\/div>At DEMOS GLOBAL GROUP, we combine experience, knowledge, and commitment to offer you comprehensive consulting services in FDA regulatory matters.<\/p>\n
Our multidisciplinary team is made up of professionals with experience in international law, food quality, chemistry, biotechnology, and foreign trade. Thanks to this, we can offer comprehensive solutions tailored to the needs of each client.<\/p>\n<\/div>
<\/i>Personalized technical advice.<\/span><\/p>\n<\/div>Personalized technical advice.<\/span><\/p>\n<\/div><\/div><\/div>