Regulatory Affairs Services in USA
A robust regulatory system is important to ensure the safety, efficacy, and quality from pre-marketing to post-marketing phases of a medicinal product. The United States Food and Drug Administration (U.S. FDA) is the governing regulatory authority in the USA for medicines, medical devices, biosimilars, vaccines, food supplements, Pharmacovigilance solutions, cosmetics, and more. The Center for Drug Evaluation and Research (CDER) issues different requirements for new drugs, generic drugs, and OTC drugs including New Drug applications (NDAs) and Abbreviated New Drug Applications (ANDAs).