A regulatory submission is a formal application or request made to a regulatory agency, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), seeking approval for a product, process, or activity to be marketed or used. Regulatory submissions are typically complex and comprehensive documents that must adhere to specific guidelines and requirements set forth by the relevant regulatory agency. The purpose of a regulatory submission is to provide the regulatory agency with sufficient evidence to demonstrate that the product, process, or activity meets all applicable safety, efficacy, and quality standards. This evidence may include data from preclinical and clinical studies, manufacturing and quality control procedures, and environmental impact assessments.
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