Whether you are developing a new ingredient, food contact substance, pharmaceutical or other FDA-regulated product you must have a plan that includes an evaluation of the regulatory pathway that will bring your product to market efficiently and at the lowest possible cost. Is your product eligible for orphan drug designation? Does 21 CFR 505(b)(2) offer a pathway to FDA approval for your product? Which center at FDA has regulatory authority over your product? Ultimate success is achieved by developing a clear regulatory pathway based on a thorough understanding of the project goals.
Another key but often missed step in product development is identifying the target customer and the ultimate marketing message that will attract them. Beginning with the end in mind can make the choice of which ingredients to use much clearer. Whether you wish to develop a natural, organic or non-specialty product, Bioscience Translation & Application can help.
Our product development services cover the conventional food, functional food, dietary supplement, cosmetic, homeopathic and over-the-counter drug markets. From bath oils to dietary supplements and foods, our professional experience in product formulation and regulatory affairs provides the expertise to bring products to market with labeling and marketing materials compliant with Food and Drug Administration, United States Department of Agriculture and Federal Trade Commission regulations.
We also offer foreign language translation services. Contact us regarding your needs.
Translating scientific innovation into profitable applications