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Full Description
This book comprehensively explores the regulatory frameworks governing pharmaceutical manufacturing, quality control, and approvals in Indian pharmaceutical scenarios. Tailored for industry professionals, students, and researchers, it bridges the knowledge gaps in regulatory affairs in the pharmaceutical industry. Covering key topics such as pilot plant scale-up, SUPAC (Scale-Up and Post Approval Changes), technology transfer, regulatory requirements, and quality management systems, it offers insights into navigating the complexities of Indian regulatory requirements. A must-read for those aiming to excel in pharmaceutical regulation, the book serves as a roadmap for ensuring efficiency, safety, and compliance in pharmaceutical industries operating in India.
