GVK Biosciences Approved by Turkish Health Ministry for Bioequivalence Studies

The GVK Biosciences (GVK BIO) Clinical Pharmacology Unit at Hyderabad was inspected by a three-member delegation from Ministry of Health, Turkey and approved for conducting bioequivalence studies.

The team from the Ministry of Health, Turkey inspected the facility and carried out a detailed audit of the facility for systems and processes meeting Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) requirements, before granting approval.

Clinical Trials - Drug development and Approval
The Drug development process is a complex one, where the experimental drug or treatments goes through various stages before it could get rejected or approved.

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

The Clinical Pharmacology Unit carries out Bioequivalence studies meeting international regulatory requirements like USFDA (USA), ANVISA (Brazil), AFSSAPS (France) and WHO (World Health Organization, Geneva) and has successfully cleared their audits.

These accreditations coupled with GVK BIO's delivery engine, has helped GVK BIO build a loyal and growing list of top generic drug players globally and in India.

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GVK Biosciences (GVK BIO) announced that it has licensed its Mechanism Based Toxicity Database (MBT) to AstraZeneca.

The Clinical Laboratory is also accredited by NABL (National Accreditation Board for testing and calibration Laboratories), Department of Science and Technology, Govt of India for meeting ISO 15189:2007 standards.

Source-ANI
SRM

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