regulatory submissions

Regulatory submissions are formal documents and data that companies, especially in healthcare and pharmaceuticals, submit to government agencies to seek approval for their products. These submissions demonstrate that the product is safe, effective, and meets quality standards. They include research results, manufacturing details, and risk assessments. Regulatory agencies review these materials to decide whether the product can be marketed and sold to the public, ensuring public health and safety. Essentially, it's the official process of getting permission to offer a new medical product or drug to the market.