Description
ABOUT THE BOOK “Pharmaceutical World: Journey Through Drug Master File” celebrates the 35-year legacy of Shreenath Chemicals—an API manufacturer known for its unwavering commitment to quality since 1989. As part of their initiative to inspire excellence among industry professionals, this book serves as a powerful knowledge resource on one of the most vital pillars of pharmaceutical regulation: the Drug Master File (DMF). Written for professionals, regulatory experts, and students, the book transforms complex regulatory concepts into clear, practical guidance. It explains the purpose, structure, and global significance of DMFs, including detailed insights on Type II Drug Substance DMFs, manufacturing documentation, analytical standards, and eCTD submissions. Real-world examples, review processes, and lifecycle management strategies make the content instantly applicable. With discussions on digitalization and AI reshaping regulatory documentation, the book prepares readers for the future of compliance. It stands as a definitive guide to achieving documentation excellence and strengthening global trust in pharmaceutical quality—echoing Shreenath Chemicals’ mission to manufacture quality and inspire quality across healthcare.
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