Transcription of DRUG SUBSTANCE: DEFINING REGULATORY …
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DRUG SUBSTANCE: DEFINING REGULATORY …
CONFIDENTIAL 2015 PAREXEL INTERNATIONAL CORP. drug substance : DEFINING REGULATORY starting MATERIALS June 9th, 2015 Aloka Srinivasan, , Principal Consultant 2015 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 2 BOSTON, MASSACHUSETTS 2 INTRODUCTION 2015 PAREXEL INTERNATIONAL CORP. / CONFIDENTIAL 3 In recent years, there has been a steep rise in the number of questions asked about the choice of REGULATORY starting Materials (RSM) for Active Pharmaceutical Ingredients (APIs) from FDA as well as other REGULATORY agencies in the world. REGULATORY authorities are worried that the RSM is shifting more and more towards the API, which has the probability of causing significant risk to API quality, and may also lead to problems in life cycle management.
CONFIDENTIAL © 2015 PAREXEL INTERNATIONAL CORP. DRUG SUBSTANCE: DEFINING REGULATORY STARTING MATERIALS June 9th, 2015 Aloka Srinivasan, Ph.D., Principal Consultant
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