We feel pleasure in presenting this book entitled, ?Regulatory Affairs? for meeting the requirements and demands of M.Pharmacy and B.Pharmacy students. We aim to give a easier shape for this notable work which is done for the betterment studies of candidates who are doing post-graduation in Pharmacy and a also a basic entity for Degree graduation in Pharmacy. With immense pleasure in preparation of this book in the subject of Regulatory Affairs, it is worthful as per the new syllabus given by Pharmacy Council of India. We have taken great care to cover the syllabus of M.Pharmacy without any single omission. We have assumed no previous knowledge of the topics covered but the student is expected to be aware of fundamental concepts. We wish to place on record my sincere thanks to the publisher for the kind cooperation and valuable suggestions. We are also indebted to our colleagues for giving notable suggestions of which we have been glad to take advantage.