About the Book: 

"Text Book of Regulatory Affairs, Intellectual Property Rights, Patents and Quality Assurance" by K. Ravi Shankar, N. Divya, T. Udaya Kumar, and K. Srinivas is a meticulously crafted resource that brings together various important topics related to pharmaceutical technology, regulatory affairs, and patents. The book provides conceptual information on these topics, making it an essential resource for students specializing in pharmaceutical analysis, technology, and regulatory affairs. With its comprehensive coverage and easy-to-understand language, the book aims to provide students with a single-source reference, eliminating the need to consult multiple textbooks and scientific journals. The inclusion of references after each chapter further enhances the book's utility, making it a valuable resource for students seeking in-depth knowledge.

Contents:

1.    Preformulation and Formulation Development

2.    Manufacturing-Regulatory Requirements Related to Manufacturing Formulation

3.    Regulatory Requirements for Packaging Materials

4.    Clinical Trials

5.    Intellectual Property Rights

6.    Patent

7.    Quality Assurance

8.    Quality Control Laboratory

9.    Distribution

10.    Total Quality Management

About the Authors:

K. Ravi Shankar obtained his Bachelor and Masters of Pharmacy degree in Pharmacology specialization from Andhra University. He obtained his Doctor of Philosophy from Acharya Nagarjuna University. He is enriched with 33 years of teaching and professional experience. Presently he is working as Professor in Aditya University, Surampalem, Andhra Pradesh. He published several research papers in Pharmacology and Pharmacy Practice in various reputed scientific journals and reviewer of many pharmacy journals. 8 candidates have obtained their Doctorate Degree under his guidance and 85 post graduate students have carried their M.Pharm  Projects. He is an author of Pharmacology I, Pharmacology II, Pharmacology III, Social & Preventive Pharmacy, Clinical Pharmacy and Pharmacotherapeutics, Pharmacology- A Comprehensive Approach and Pharmacology, A Companion Handbook with illustrations published by Pharm Med Press Pvt Ltd., 

N. Divya was graduated from Acharya Nagarjuna University and obtained Master of Pharmacy Degree with Pharmaceutical Analysis Specialization from VELS University, Chennai. She obtained Doctoral Degree from Acharya Nagarjuna University. She is having 14 years of teaching experience and presently working as Professor in Aditya University, Surampalem, A.P. She has published 10 research papers in reputed journals and has 3 Book Chapters, she has guided several B.Pharm projects and she is actively involved in college Consultancy works. She is specialized and acquired expertise in handling all sophisticated equipments. 

T. Udaya Kumar obtained his B.Pharm & M.Pharm Degrees from Rama Krishna College of Pharmacy, Coimbatore affiliated to Dr. M.G.R. Medical University, Tamilnadu. He obtained his Doctor of Philosophy from Jawaharlal Nehru Technological University Kakinada, and he is having 17 years of teaching experience and presently working as Professor in Aditya University, Surampalem, A.P. He has published 12 research papers in reputed scientific journals and has 3 Books Chapters. He has guided several B.Pharm and M.Pharm students during their project works. He also worked in Laurus Labs in Research & Development Department and familiar with various GMP procedures related to Pharmaceutical Industry.