Pharmaceutical Regulatory Affairs

This book presents essential information clearly, with suitable emphasis on the concrete aspects of each topic. This book is an essential resource for students pursuing careers in pharmaceutical research, development and manufacturing, providing them with the knowledge and tools needed to navigate the complex regulatory landscape and ensure compliance with regulations.

Salient features of the book

The content of this book is well organized in ten chapters and written in simple and easy to understand language.
The entire text has been written in such a flow so as to cover all the three relevant subjects.
This book covers the entire scope of pharmaceutical regulatory affairs including needs, significance, regulations and regulatory agencies.
Chapters and topics are organized and named in accordance with the focus on pharmaceutical regulations and regulatory science.
Important key learning points, common questions and useful references have given in each chapter.
Inside you will find

Pilot plant, SUPAC guidelines, post-marketing surveillance, technology transfer, quality risk management,

regulatory authorities, drug development teams, new drug application, abbreviated new drug application, regulatory agencies, quality management systems, total quality management, quality by design, international organization for standardization, pharmaceutical regulatory agencies in India, new drug discovery and development, registration of Indian drug products in overseas market, DMF, CTD and its modules, clinical trials studies, good clinical practice, pharmacovigilance, and ICH guidelines.