GVK Biosciences wins Turkish approval for bioequivalence studies

GVK Biosciences, an Indian contract research organization, has obtained approval from the Ministry of Health of Turkey for bioequivalence studies.

This approval enables GVK Biosciences to cater to generic drug manufacturers in Turkey as well as to those who intend to market their generic drug products in Turkey.

GVK Biosciences’s clinical pharmacology unit at Hyderabad was inspected by a three-member delegation from Turkey’s Ministry of Health. The team inspected the facility and carried out a detailed audit of the facility for systems and processes meeting Good Clinical Practice and Good Laboratory Practices requirements, before granting approval.

The Clinical Pharmacology Unit (CPU) located at Hyderabad, is used for Bioavailability and Bioequivalence studies with state-of-the-art infrastructure to cater to global regulatory requirements. This CPU with 144 beds and a comprehensive volunteer database has the capability of undertaking studies for special population and dosage forms like injectables in addition to the conventional studies, which sets it apart from the competition. As of now, CPU has conducted around 500 studies of which 100 studies are for USFDA submission.

The clinical pharmacology unit carries out bioequivalence studies meeting international regulatory requirements like the FDA (US), ANVISA (Brazil), AFSSAPS (France) and WHO (World Health Organization, Geneva) and has successfully cleared their audits, said GVK Biosciences.

GVK BIO, a contract research services company and delivers integrated research services pharmaceutical and biotechnology companies. GVK has a diverse customer portfolio of 15 pharma companies and agri & life-sciences companies and academic institutions and has facilities in Hyderabad, Chennai, Mumbai and Gurgaon in India.