The pharmaceutical industry operates within a complex framework of regulations designed to ensure the safety, efficacy, and quality of medicinal products. As the global landscape of healthcare continues to evolve, the role of regulatory affairs has become increasingly critical in bridging the gap between scientific innovation and public health. This book, developed in alignment with the M. Pharmacy syllabus, is intended to serve as a comprehensive guide for students, educators, and professionals seeking a foundational and practical understanding of regulatory affairs. It encompasses the essential principles, guidelines, and procedures governing the development, approval, and post-marketing surveillance of pharmaceutical products across major regulatory jurisdictions.