Mumbai: Wellquest, Nicholas Piramal's clinical research division, has added a new clinical section, equipped with a 52-bed ward, a 6-bed ICU and enhanced services for clinical trials and data management. It will undertake Phase I-III studies in order to consolidate its position in the rapidly growing clinical research services sector. Dr. William Haseltine of Human Genome Sciences Inc., USA, formally opened the facility and addressed a gathering of Biotechnology and Pharmaceutical experts.
Wellquest is fully compliant as per international requirements and the GCP guidelines of ICH and also as per the code of federal regulations of the US-FDA.
Speaking at the inauguration of the new section, Dr. Satish Bhatia, President Wellquest said, ''We are poised for rapid growth with such augmented infrastructure. Wellquest will continue to provide its quality services in clinical research to the international pharmaceutical industry.''
Several leading national and international Pharma companies who are currently on its list of clients have audited Wellquest. The regulatory bodies of UK, Europe and Latin America have approved the Wellquest dossiers. Wellquest is the only Indian Clinical Research Organization to have undergone positive facility audits by the UK-MHRA, Brazil-ANVISA and Israel-MOH.
The CRO, recognized by the Drugs Controller General of India (DCGI), has now received further incentive from the Government of India to export its services and seek waiver of customs duty for the import of expensive laboratory equipment.
Established in 2000 by Nicholas Piramal India Limited as an independent division, Wellquest's state-of-the-art facilities occupy 20,000 sq ft of space over four floors of the Wellspring Hospital in Mumbai. The infrastructure consists of spacious clinical wards, drug store, phlebotomy stations, archives and sophisticated bioanalytical laboratories and a NABL-accredited central path-lab.
The bioanalytical section at Wellquest already has two LC/MS/MS machines and it plans to increase the number to four. Wellquest provides in-house services for Phase I healthy volunteer studies with NCEs, herbal and biotech products and for the assessment of bioequivalence of generic products. It maintains a database of over two thousand healthy volunteers for such studies.