Drug Regulatory Affairs /

Singh, Gajendra,

Drug Regulatory Affairs / Gajendra Singh, Gaurav Agarwal & Vipul Gupta. - 1st ed. - 192 pages : illustrations ; 23 cm

A practical guide detailing regulatory requirements governing drug development, approval, manufacturing, and monitoring. Covers regulatory bodies' roles, clinical trial regulations, pharmacovigilance, GMP standards, and global guidelines—ideal for students and professionals in pharmaceutical regulatory affairs.


9788123928814


Drug approval --Regulatory aspects.
Pharmaceutical regulation.
Clinical trials$xLegislation & jurisprudence.

635.1 / S.G.D