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European Medicines Agency PPT/PDF
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) PPT/PDF
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 Products Evaluation of Medicines for Human Use PPT/PDF
The European Agency for the Evaluation of Medicinal ProductsEvaluation of Medicines for Human Use London, 21 October 1999CPMP/BWP/328/99…
FINAL DOCUMENT Global Harmonization Task Force PPT/PDF
GHTF/SG1/N063:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the…
SCOPE AND OPPORTUNITIES IN NUTRACEUTICAL MARKET PPT/PDF
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 PPT/PDF
Regulation of Medical Devices in South-East Asian Nations Department of Drug Regulatory Affair College Of Pharmacy www.DuloMix.com 1…
SUPPLEMENTAL NEW DRUG APPROVAL PROCESS (SNDA) PPT/PDF
www.DuloMix.com 1 SUPPLEMENTAL NEW DRUG APPROVAL PROCESS (SNDA) www.DuloMix.com Manufacturer of new drug applications (NDAs) and abbreviated…
US: Dietary Supplement Health And Education ACT of 1994 PPT/PDF
US: Dietary Supplement HealthAnd Education ACT of 1994 Supplementary Legislation U/S 411 of “ Federal Food, Drug and…
REGULATORY APPROVAL PROCESS OF NDA PPT/PDF
REGULATORY APPROVAL PROCESS OF NDA WWW.DULOMIX.COM 1 For the new drug approval process following steps are followed…
Medical Devices Regulations in Japan PPT/PDF
Medical Devices Regulations in Japan Presented by-Aditya Kekan(Roll no.04) Rushikesh Koshti(Roll no.05)Anju Choudhary(Roll no.06) www.DuloMix.com Guided by-Dr. Ravindra…