Basic Regulatory Guidelines: For Pharmaceutical Industry - Tapa blanda

Sinopsis

This book is designed to help readers understand the regulatory framework that governs the development, manufacturing, registration, approval, and post-marketing activities of pharmaceutical products. It covers essential concepts such as regulatory authorities, drug development, regulatory submissions, dossiers, documentation, quality requirements, compliance, and major regulatory guidelines.Written in a simple, structured, and reader-friendly manner, this book brings together the basic concepts that every student and beginner should know before entering the field of Regulatory Affairs. It aims to make regulatory concepts easier to understand by presenting important principles and processes in an organized way.It is a useful introductory reference for pharmacy students, fresh graduates, Regulatory Affairs professionals, Quality Assurance professionals, and anyone interested in developing a strong foundation in pharmaceutical regulatory requirements.

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