Regulatory Compliance Experts in the USA
A strong regulatory framework is essential to ensure the safety, efficacy, and quality of medicinal products throughout all stages—from pre-market development to post-market surveillance. In the United States, the Food and Drug Administration (FDA) serves as the primary regulatory authority overseeing medicines, medical devices, biosimilars, vaccines, dietary supplements, pharmacovigilance services, cosmetics, and more.
The FDA’s Center for Drug Evaluation and Research (CDER) outlines distinct regulatory requirements for various drug categories, including New Drug Applications (NDAs) for novel drugs, Abbreviated New Drug Applications (ANDAs) for generics, and specific protocols for over-the-counter (OTC) products. For biological products, premarket approval must be obtained through a Biologics License Application (BLA).
Due to the complexity and rigor of FDA regulations—which are also often adopted by other regulatory bodies globally—manufacturers must navigate a challenging compliance landscape to secure market authorization. This can be particularly difficult for foreign manufacturers, many of whom struggle to meet these evolving regulatory standards.
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