Regulatory affairs

WHO Guidelines on Nutrition NSF International : Its Role in Dietary Supplement and Nutraceuticals Industries www.DuloMix.com 1  …

VACCINES REGULATIONS IN INDIA,EUROPEAN UNION & US DEPARTMENT OF DRUG REGULATORY AFFAIRSwww.DuloMix.com   Silver Spring, Maryland, United States…

USFDA Dietary Supplements Class : F.Y.M.Pharm (DRA) www.DuloMix.com 1   Dietary supplements As per DSHEA, Dietary supplements •…

European Medicines Agency July 1996 CPMP/ICH/138/95   ICH Topic Q 5 C Quality of Biotechnological Products: Stability Testing…

18 December 2014 EMEA/CHMP/BMWP/42832/2005 Rev1 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal…

The European Agency for the Evaluation of Medicinal ProductsEvaluation of Medicines for Human Use London, 21 October 1999CPMP/BWP/328/99…

GHTF/SG1/N063:2011   FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the…

www.DuloMix.com 1   • Introduction: Nutraceuticals-“A food or part of food or nutrition, that provides health benefits, including…

Regulation of Medical Devices in South-East Asian Nations Department of Drug Regulatory Affair College Of Pharmacy www.DuloMix.com 1…

www.DuloMix.com 1 SUPPLEMENTAL NEW DRUG APPROVAL PROCESS (SNDA)   www.DuloMix.com Manufacturer of new drug applications (NDAs) and abbreviated…