Friday, March 29, 2024

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...

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...

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...

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,...

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...

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...

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...

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...