Hyderabad-headquartered GVK has announced that its Ahmedabad Clinical Pharmacology Unit successfully cleared the US (Food and Drug Administration) FDA Audit with no 483s observations.
GVK explained that the visit was prompted by an unnamed customers request to carry out a first-to-file study for a generic drug product.
The facility – which is used primarily Bioavailability and Bioequivalence (BA/BE) studies - has 110 beds and has been inspected and approved by Drugs Controller General of India (DCGI), ANVISA-Brazil and Ministry of Health (MoH)-Turkey.
Manni Kantipudi, GVK CEO, said: "This is a clear testimony of the high standards of quality and processes followed at GVK BIO. 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."
ClinTec in Malawi
Meanwhile in Malawi, Africa UK-based contract research organization (CRO) ClinTec International has gone on a hiring spree in a move also prompted by a customer request.
In a statement released earlier today ClinTec said it has appointed a team of experienced research associates (RA) following an unnamed top 5 pharmaceutical company’s selection of the CRO as its partner for =vaccine development in Africa and Asia.
CEO Rabinder Buttar stated: “I am pleased with our continued expansion in Africa and see huge potential for the company in conducting large scale vaccine trials. Despite the challenging economic conditions through which many of our clients are restructuring their organisations, ClinTec continues to grow and win major new business from pharma companies.
“The company is continuing to expand into interesting new regions for clinical research. As the pharmaceutical industry increasingly focuses its drug development efforts on the emerging markets, ClinTec will closely partner with its clients, aligning its services and operations to fit with their needs”.