Журнал фармацевтических наук и новых лекарств

The Role of Regulatory Affairs in Pharmaceutical Quality Assurance

Pharmaceutical quality assurance is a critical component of the drug development and manufacturing process. It ensures that pharmaceutical products are safe, effective, and meet the required quality standards. Regulatory affairs play a pivotal role in maintaining and enhancing pharmaceutical quality assurance. This study explores the multifaceted role of regulatory affairs in pharmaceutical quality assurance, emphasizing its importance, challenges, and impact on patient safety