Saturday, November 18, 2017

Regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"

Regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain" On the outer packaging of pharmaceutical products one often finds labels with storage requirements like, for...

Quality by design approach: Regulatory Aspect………..!!!

Quality by design approach: Regulatory Aspect.......... In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces...

Bioavailability and Bioequivalance the Basic Approach…..

Bioavailability: Bioavailability is a measurement of the extent of a therapeutically active medicine that reaches the systemic circulation and is therefore available at the site...

BIOWAIVER….The Way Forward..

BIOWAIVER:  The term biowaiver is applied to a regulatory approval process when the application (dossier) is approved on the basis of evidence of equivalence other than an...

DMF (Drug Master File)

DMF A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities,...

Drug Regulatory Agencies across the world

S.No. Country /Region                                Regulatory Agency 1 United States of America United States Food and...

Regulatory Affairs & its Role in Pharmaceutical

What is Regulatory Affairs Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across...

Effective Dossier Management in Regulatory Affairs

Importance of effective dossier management- The registration dossier for medicines is an important document which is submitted for review to regulatory agencies by pharma companies for approval to...