Biologics Submission

Biologics submission is the process where a company provides detailed scientific information to regulatory authorities to get approval for a complex medicine made from living organisms, such as vaccines or antibody therapies. This involves submitting data from laboratory tests, clinical trials, manufacturing methods, and safety assessments. The goal is for regulators to review the information to ensure the biologic is effective, safe, and consistently produced. Once approved, the biologic can be marketed and used to treat patients. This process ensures high standards and patient safety before the biologic enters the healthcare system.