Regulatory Submission

A regulatory submission is a formal process where a company provides detailed information to government agencies to gain approval for a product, such as a new medication or medical device. It ensures the product meets safety, efficacy, and quality standards before it reaches the market. The submission includes data from clinical trials, manufacturing details, and risk assessments. Regulatory authorities review this information thoroughly to decide whether the product is safe for public use. This process is essential for protecting public health and ensuring that innovative products are appropriately evaluated before they become available.