Regulatory Affairs: Basic Protocols

Regulatory Affairs: Basic Protocols provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner this book covers topics including documentation chemistry manufacturing and controls as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book readers will learn about the concept of innovator and generic drugs drug development and the regulatory guidance and guidelines for filing and approval. This book also explores the preparation of dossiers and their submission to regulatory agencies in different countries as well as post-approval regulatory requirements for actives and drug products. Readers will also gain valuable insights into the submission of global documents in CTD/eCTD formats clinical trial requirements for approvals for conducting clinical trials pharmacovigilance and the process of monitoring clinical trials. Regulatory Affairs: Basic Protocols is an indispensable resource for anyone looking to gain a deeper understanding of the regulatory affairs landscape in the pharmaceutical industry. With clear descriptions helpful figures and illustrative examples this book will make the subject more accessible and interesting for any reader.