« Return to News | CROs/Service Providers

GVK Bioscience’s Ahmedabad clinical pharmacology unit clears FDA audit

Monday, July 30, 2012 09:52 AM

GVK Biosciences, an Asian CRO, announced that its Ahmedabad Clinical Pharmacology Unit has successfully cleared an FDA audit with zero 483s/observations from the agency. FDA visited and audited a First-to-File study for one of GVK BIO’s customers.

The GVK Ahmedabad facility, commissioned in 2010, has three clinics with 110 beds. The facility has been inspected and approved by drugs controller general of India, Anvisa-Brazil and Ministry of Health (MoH)-Turkey. The Ahmedabad facility carries out bioavailability and bioequivalence (BA/BE) studies that are submitted to various regulatory agencies including FDA, TGA (Australia), European Regulatory agencies, Health Canada, Anvisa-Brazil and MoH (Turkey).

“This is a clear testimony of the high standards of quality and processes followed at GVK BIO,” said Manni Kantipudi, CEO of GVK. “The sponsor can now carry out BA/BE studies at either of our sites—Ahmedabad or Hyderabad—with a wider choice of population and capacities”.

The Ahmedabad success comes on the heels of regulatory joint inspection by FDA, ANSM (France), AGES (Austria) and WHO, of the GVK Hyderabad facility. This inspection was the first joint inspection of a CRO by the four agencies. GVK received zero 483s by FDA in this joint inspection as well. The GVK BIO Hyderabad facility is a full service provider of BA/BE services with four clinics and 144 beds supported by a bioanalytical facility with 16 LC-MS/MS machines.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

February 25

Analysts: With market anticipation of Quintiles IPO, other CROs could soon file to go public

National Clinical Trial Network aims to link sponsors, minority patients for trials and access to new therapies

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

March

Sites rate the best
sponsors of 2013
Largest survey response ever puts Biogen Idec, Forest Labs, Bayer at top

As CRO industry
turns 30, a look back
at modest beginnings
Phenomenal growth, strategic partnering highlight evolution
of CROs

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

February

Sized out of big deals,
mid-tier CROs still thriving
Finding market niches, strategies to stay vital in changing research enterprise

Industry leaders embrace disruptive innovations
Despite resistance to change, many exploring data sharing, open-source collaboration

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.