Browsing Tag
Regulatory affairs
157 posts
Guideline on similar biological medicinal products. PDF
18 December 2014 EMEA/CHMP/BMWP/42832/2005 Rev1 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal…
Summary Technical Documentation (STED) for Demonstrating . PDF/PPT
GHTF/SG1/N063:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the…
Nutraceuticals Scope Opportunities: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
www.DuloMix.com 1 SUPPLEMENTAL NEW DRUG APPROVAL PROCESS (SNDA) www.DuloMix.com Manufacturer of new drug applications (NDAs) and abbreviated…
Dietary Supplement Health And Education. PDF/PPT
US: Dietary Supplement HealthAnd Education ACT of 1994 Supplementary Legislation U/S 411 of “ Federal Food, Drug and…
REGULATORY APPROVAL PROCESS OF NDA. PDF/PPT
REGULATORY APPROVAL PROCESS OF NDA WWW.DULOMIX.COM 1 For the new drug approval process following steps are followed…
Medical Devices Regulations in Japan. PDF/PPT
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…
Medical Devices are regulated in China, PDF/PPT
www.DuloMix.com 01 INTRODUCTIONRegulatory Body :● Medical Devices are regulated in China by the National Medical Products Administration…
INTRODUCTION TO NEUTRACEUTICALS. PDF/PPT
INTRODUCTION TO NEUTRACEUTICALS WWW.DULOMIX.COM 1 www.DuloMix.com 2 www.DuloMix.com 3 INTRODUCTION • TWO HUNDRED YEARS AGO,…