A Concise book on Pharmaceutical Regulatory Affairs. As per the latest syllabus of PCI for B. Pharm semester VII students and M. Pharma Semester I students in India

      Аннотация: The book entitled Pharmaceutical Regulatory Affairs will be useful for the students of UG/PG courses of Pharmacy in India as well as other global universities. Currently there are many books available in market but most of them are used as reference book, no one is a text book or concise review book for students. The book is written for UG/PG students in brief content as per the syllabus of PCI in India. This is better for students for exam preparation but should not be used as reference book by regulatory/industry persons. This book does not contribute to research instead it give insight of regulatory guidelines and agencies in very brief and informative way.

Ключевые слова: NDA, ANDA, DMF, INDA, USFDA, MHRA, CDCSO, ANVISA, TGA