"It was a wonderful experience interacting with you and appreciate the way you have planned and executed the whole publication process within the agreed timelines.”
Subrat SaurabhAuthor of Kuch Woh Pal
Comprehensive Guide to Pharmaceutical Regulatory Affairs is an essential resource for anyone involved in the pharmaceutical industry, particularly those working in regulatory affairs. This book provides a thorough understanding of the principles and practices that ensure the safety, efficacy, and quality of pharmaceutical products.
It begins with Good Regulatory Practices, providing a strong foundation in the basic principles of regulatory affairs. Subsequent chapters delve into Good Laboratory Practices, Good Automated Laboratory Practices, and Good Distribution Practices, each offering detailed insights into maintaining high standards across different stages of pharmaceutical production and distribution.
The section on Quality Management Systems explores the implementation of effective quality assurance mechanisms, ensuring that all pharmaceutical products meet stringent quality standards. Detailed chapters on Documentation and Regulatory Writing, Dossier Preparation and Submission, and Audits offer practical guidance on the critical documentation processes and audit procedures required for regulatory approval and ongoing compliance.
The book also addresses the complexities of Inspections and Product Life Cycle Management, providing comprehensive guidance on maintaining compliance throughout the product lifecycle. A comprehensive List of Abbreviations and Acronyms and a detailed Bibliography serve as valuable reference tools, enhancing the utility of this guide.
Muralidhar Rao Akkaladevi, Veerareddy Prabhakar Reddy
Dr. A. Muralidhar Rao is the distinguished Principal of St. Mary's College of Pharmacy and President of the Association of Pharmacy Professionals for Telangana State. With over 25 years of teaching experience, Dr. Rao has made significant contributions to pharmacy education and research. He is the author of 15 books on various pharmacy topics and has published numerous research papers.
Dr. Rao is a Fellow of the Association of Pharmacy Professionals (APP) and the Indian Science Congress Association (ISCA). He is also a life member of the Association of Pharmaceutical Teachers of India (APTI), the Indian Pharmacy Graduates' Association (IPGA), and the Indian Pharmacological Society (IPS). A respected speaker, he has presented at national and international conferences, sharing his expertise and inspiring others in the field
Dr. Prabhakar Reddy Veerareddy is the Principal at University College of Pharmaceutical Sciences, Palamuru University, Telangana. With a B.Pharm from Kakatiya University, an M.Pharm from Andhra University, a Ph.D. from Kakatiya University, and a Post-Doctoral Fellowship from Butler University, USA, he is a distinguished educator and researcher. Dr. Reddy has received numerous fellowships and awards, published two books, and holds one patent. He has an h-index of 28 with over 2200 citations. His research spans drug delivery systems and nanotechnology. Dr. Reddy is a member of several professional organizations and has delivered over 80 invited talks globally.
