GVK Biosciences, a contract research organisation, today announced that its clinical pharmacology unit at Ahmedabad has cleared the US drug regulatory audit.
The United States Food and Drug Authority (USFDA) team visited and audited the facility which was commissioned in 2010. It has three clinics with 110 beds. It has already got approval from the Indian, Brazilian and Turkish regulators.
The facility carries out important scientific studies related to drug development for pharma customers (drug companies, research institutes etc) and submits them to various regulatory authorities.
Studies can be done on healthy human volunteers, in special populations and some specific patient-based, a release from the company said.
The Chief Executive Officer of GVK Bio, Mr Manni Kantipudi, said now customers have a choice of going to Ahmedabad or Hyderabad, which already has regulatory approvals.
The Hyderabad facility has four clinics and 144 beds with necessary scientific equipment.
Since its establishment in 2003, the company has completed over 750 studies, including those intended for regulatory submissions.