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.