{"product_id":"volume-1-comprehensive-guide-to-pharmaceutical-regulatory-affairs-principles-and-practices-9798895199244","title":"Volume 1: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices","description":"\u003cp\u003e • Author(s): Muralidhar Rao Akkaladevi | Veerareddy Prabhakar Reddy\u003cbr\u003e • Publisher: Notion Press\u003cbr\u003e • Publisher Imprint: Notion Press\u003cbr\u003e • BISAC: Research\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eComprehensive 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.\u003c\/p\u003e\u003cp\u003e It begins with\u003cstrong\u003e Good Regulatory Practices, \u003c\/strong\u003e providing a strong foundation in the basic principles of regulatory affairs. Subsequent chapters delve into \u003cstrong\u003eGood Laboratory Practices, Good Automated Laboratory Practices, and Good Distribution Practices\u003c\/strong\u003e, each offering detailed insights into maintaining high standards across different stages of pharmaceutical production and distribution.\u003c\/p\u003e\u003cp\u003eThe section on \u003cstrong\u003eQuality Management Systems\u003c\/strong\u003e explores the implementation of effective quality assurance mechanisms, ensuring that all pharmaceutical products meet stringent quality standards. Detailed chapters on\u003cstrong\u003e Documentation and Regulatory Writing, \u003c\/strong\u003e \u003cstrong\u003eDossier Preparation and Submission\u003c\/strong\u003e, and Audits offer practical guidance on the critical documentation processes and audit procedures required for regulatory approval and ongoing compliance.\u003c\/p\u003e\u003cp\u003eThe book also addresses the complexities of \u003cstrong\u003eInspections and Product Life Cycle Management\u003c\/strong\u003e, providing comprehensive guidance on maintaining compliance throughout the product lifecycle. A comprehensive \u003cstrong\u003eList of Abbreviations and Acronyms and a detailed Bibliography serve as valuable reference tools, \u003c\/strong\u003e enhancing the utility of this guide.\u003c\/p\u003e","brand":"Atlantic Books","offers":[{"title":"Paperback","offer_id":46384318906519,"sku":"9798895199244","price":2528.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9798895199244.webp?v=1768782579","url":"https:\/\/atlanticbooks.com\/products\/volume-1-comprehensive-guide-to-pharmaceutical-regulatory-affairs-principles-and-practices-9798895199244","provider":"Atlantic Books","version":"1.0","type":"link"}