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FDA Consultant Services

 

fda consultantOur FDA Consultant Services are comprehensive and industry and product-specific to help our clients develop products that are compliant with federal laws and regulations. From ingredient reviews to label reviews, FDA registration and marketing reviews, we provide extensive FDA Consultant Services to meet the needs of clients at every level and stage in the manufacturing and marketing process.

Ingredient reviews are used to determine whether particular products, as currently formulated, may be legally marketed in the United States without further regulatory approval. Because some ingredients may only be used in products that are classified as drugs, it is important to know whether your formulation would cause your product to be regulated more stringently and require pre-approval. Additionally, because FDA regulations pertaining to labels are very detailed and complex, many companies look to FDA Consultant Services to help ensure compliance with FDA labeling requirements.

FDA Consultant – Ingredient Reviews

Because products are regulated based on both their ingredients and intended use, ingredient reviews are often the first stage in determining how products are regulated and whether the products may be marketed in the United States at all. In addition, FDA regulates the names of ingredients on product labels. For instance, under FDA regulations ingredients generally must be declared according to their common or usual name. These regulatory requirements are applicable to foods, dietary supplements and other FDA-regulated products like cosmetics. More information about FDA regulations pertaining to ingredient declarations may be accessed here.

FDA Consultant – Label Reviews

The FDA has very specific requirements for the labels of the products it regulates. From the placement of information, to the formatting of the Nutrition Facts Panels and required statements, such as the Net Quantity of Contents, Statement of Identity, etc., compliance with FDA regulations can be a daunting process, but it doesn’t have to be this way. With our FDA Consultant Services, label reviews are a key way of how we help our clients ensure that their product labels are fully compliant with FDA regulations.

If you would like to know more about FDA Consultant Services or how hiring a FDA regulatory attorney can help you ensure that your labels are in compliance with FDA regulations, please feel free to contact us by phone at (786) 780-1544 or by email at contact@giannamore-law.com.

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