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Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics, and complementary medicines. Companies responsible for the discovery, testing, manufacture, and marketing of these products must ensure the sale of safe and effective products. Drug Regulatory Affairs refers to the fulfillment of all aspects of drug regulations within the pharmaceutical companies from the development process to finished product marketing.
The book provides a sound basis for an understanding of international drug regulatory guidelines controlling the quality, safety, and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in the pharmaceutical industry.
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Arindam Maiti
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