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...
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...
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,...
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 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...
