UReg – FDA Registrations provides services to a wide array of clients seeking to register and remain compliant with the FDA and its many rules and regulations.
All food supplied in the United States is controlled by the FDA. The FDA controls the quality, toxicity, and accurate labeling of foods. Both foods and supplements must contain licensed ingredients, must be labeled, must comply with sound production standards, and must only make claims for foods and dietary supplements that follow the strict FDA guidelines.
The rules of the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act, and other federal legislation apply to cosmetics labeled in the US, which cosmetics must conform to. Regulations related to authorized labeling, authorized ingredients, and statements that may be made for cosmetic labeling have been provided by the United States FDA. To ensure that they comply with these requirements is the prerequisite of the cosmetics sector.
Pharmaceuticals and OTC medications are among the most highly-regulated goods on the market. Via one of the many application procedures, generic drugs must undergo FDA clearance, the most common being New Drug Applications (NDA). Over-the-counter products, also known as OTC, must comply with stringent rules on labeling, production, and additives. Such rules for OTC medications are referred to as OTC monographs. Homeopathic medicines, whether prescription or OTC, must follow a homeopathic monograph, close to conventional allopathic OTC drugs. These monographs are carefully in the Homeopathic Pharmacopoeia of the United States.
The Food and Drug Administration (FDA) of the United States oversees several other products outside what their name suggests for food and drugs. Cosmetics, dietary supplements, homeopathic remedies, medical equipment, laser devices, tobacco products, vaccines, blood and biologics, animal and veterinary foods, medications and supplements, and products that emit radiation are also regulated by the FDA.
UReg – FDA Registrations has over 20 years combined experience with FDA registrations. Lisa Capote and Andrina Capote launched this site after realizing there was a need for a simple, fast FDA registration process. Lisa and Andrina realized that there were a number of FDA registrations that were incorrectly done or not done at all because of the time and effort it took to manage. They decided they would create a website that would be user friendly and have quality checks done by experienced individuals. Individuals who could also spot other potential compliance issues, one that had gone undetected, sometimes for years.