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  • Format: ePub

Pharma Fact 5 Regulatory Affairs is a concise yet comprehensive guide that unravels the critical role of Regulatory Affairs (RA) in the pharmaceutical industry. Designed for students, professionals, and industry aspirants, this book bridges theory with real-world applications through five well-structured "Facts," each enriched with practical case studies and insights.
It explores the entire regulatory journey from dossier submissions and GMP compliance to global harmonization and the future of digital regulatory systems. The book highlights how RA professionals ensure safety, quality, and
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Produktbeschreibung
Pharma Fact 5 Regulatory Affairs is a concise yet comprehensive guide that unravels the critical role of Regulatory Affairs (RA) in the pharmaceutical industry. Designed for students, professionals, and industry aspirants, this book bridges theory with real-world applications through five well-structured "Facts," each enriched with practical case studies and insights.

It explores the entire regulatory journey from dossier submissions and GMP compliance to global harmonization and the future of digital regulatory systems. The book highlights how RA professionals ensure safety, quality, and efficacy while navigating complex global requirements.

With simplified explanations, structured learning, and relatable industry examples, Pharma Fact 5 Regulatory Affairs serves as a practical reference and a learning companion for anyone aspiring to master the art and science of regulatory compliance.


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