The effort has been mainly to focus on the primary aspects for students of postgraduate courses in pharmacy and people working in DRA department of pharmaceutical industry. It seems to be one of the finest efforts of its own kind to offer a wide range of various fundamentals in this field from the very traditional to the modern trends of regulatory affairs in pharmaceuticals. The text deals not only with the basic concepts but also emphasizes the technical and practical aspects of the subject. This book will help in bridging the existing gap of knowledge among budding pharmacy technocrats, academicians and scientists, especially the young professionals of drug regulatory department in pharmaceutical industry.