Friday, September 17, 2021

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...

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...

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...

Drug Regulatory Agencies across the world

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

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...

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...

EU and US agree to share API and drug plant inspection data…!!!

The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed between...

Reasons for FDA violations….

Reasons for FDA violations.... Most FDA violations involve one of the following: Not having procedures in a regulated area that conform to FDA regulations; Having...