Human tissue consulting firms is essential in the process of introducing human tissue and biological products into the market. They are the ones responsible in making the right strategy on how to introduce and present the products into the market. Also, they must develop the right strategy in establishing a good and harmonious relationship with the Food and Drug Administration. The Food and Drug Administration or commonly known as the FDA is the government agency that is concerned in the regulation of human tissue and biological products. They regulate the products in accordance with the provisions set in the Food, Drug and Cosmetics Act (FD&C Act) and the Title 21 of the Code of Federal Regulations (21CFR). According to the provisions of the Act, it is not only the product that must be regulated. The regulation must also include the establishments that manufacture the product. This is to make sure that the products are safe, potent and effective.


