Regulatory affairs in pharmacy is gaining importance today as itis the inter disciplinary subject useful for student, teaching and pharmaceutical industry community. Serious attempt is made for a comprehensive introduction to the subject. The presentation of the contents, subject matter, illustrations, diagrams are vivid and the language is made in a lucid way for easy understanding of concept, Keeping in view with better understanding for graduate and postgraduate of pharmacy. The concept is a comprehensive description of Regulatory affairs making it appropriate for pharmaceutical Industries & Institutional purpose. Inspite of great care there may be mistakes and deficiencies, we will be very grateful in welcoming suggestions regarding the same.