Drug Regulatory Affairs

Drug Regulatory Affairs involves ensuring that medicines and healthcare products meet safety, effectiveness, and quality standards before they reach the market. Professionals in this field coordinate with government agencies to prepare and submit documentation, trials, and approvals needed for a drug’s launch. They also monitor ongoing safety after approval, ensuring compliance with regulations. Essentially, it bridges the gap between pharmaceutical companies and regulators, ensuring that new medicines are safe for public use and adhere to legal standards throughout their lifecycle.