The exponential growth in the natural product and dietary supplements field requires clinical trials to support safety and efficacy. Innovate Research lends support at every step of your clinical trial journey to help you carve a niche in the dietary supplement market allowing you to grow your market size and facilitate product differentiation. Our team of experts are here to help understand your requirements and provide solutions in accordance with regulatory requirements.

Unlike drugs that require premarket approval by the FDA prior to marketing, dietary supplements intended for the purposes of affecting the structure and function of the human body are not subject to approval under the Dietary Health Supplement and Health Education Act of 1994 (DSHEA). However, the manufacturers of dietary supplements must ensure that their products are manufactured in accordance with Good Manufacturing Practice (GMP) guidelines, are labelled accurately, and are safe and free of contaminants. The European Union (EU) regulations for supplements also supports health benefits and not therapeutic or medicinal claims. However, if the dietary supplement is intended to be used as a drug to diagnose, cure, mitigate, prevent, or treat a disease an IND is required to conduct clinical investigations in humans.