A TEXTBOOK OF DRUG REGULATORY AFFAIRS. IN MAJOR REGULATED COUNTRIES-UNITED STATES, EUROPE, INDIA

      Аннотация: This book has been written to create a road map for the aspects of Drugs, Biologics, Medical devices as well as Nutraceuticals in U.S.A, Europe, India. This book covers the legal regulations and requirements of the above-mentioned aspects and the laws about their development. It is meant to be a concise reference that offers current, real-time information. The book can be used as a handy reference by students, staff and professionals at corporations, organizations and colleges belonging to this particular field. The new courses lay great emphasis on legislations & regulations of various countries in particular and other professional aspects in general.

Ключевые слова: drug regulatory affairs, Legislations, FDA, EMA, CDSCO, Drugs and cosmetics, biologics, Medical Devices, Food and Nutraceuticals, blood products