Slide 1Dr. Raghuveer Pharma Consultants D R P C Quality. Perfection. Confidentiality. D R P C Quality. Perfection. Confidentiality. 1 Slide 2 Summary of Presentation …

DMFs Under GDUFA: DMF Basics Small Business Webinar 2013 DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. FDA DMF Expert FDA Small Business Office Webinar…

1 APPENDIX 6: GUIDELINE ON REGULATORY CONTROL OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) (Version 2.2) Outline: 1. Introduction 2. Definition 2.1 Definition of Active Pharmaceutical…

Slide 1 1 DRUG MASTER FILES / 45 Slide 2 2 CONTENTS:- Introduction Some basic terminologies. Types of DMFS with their contents. Submissions to drug master files Authorization…

Slide 1 General Overview to the CTD and Module 1 Gudrun Dora Gisladottir Director Regulatory Affairs Slide 2 Using CTD format Actavis group hf International generic pharmaceutical…

DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Drug Master Files • A Drug Master File (DMF) is a submission of proprietary information to…

CTD Dossier Preparation K. Srikantha Reddy Sr.Manager-Regulatory Affairs Medreich Limited [email protected] CTD Dossier Preparation CTD (Common Technical Document)…

BIOSIGMA Disposable Labware for Life Science 3 We are here! Graphic Project : Biosigma S.r.l. 032011 - International Depliant - Ver. 5.4 - Ed. March 2011 Since 1988 Biosigma…

DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Drug Master Files • A Drug Master File (DMF) is a submission of information to the FDA to…