QPS Bioserve India Pvt Ltd. Information

QPS in India is a GLP/GCP-compliant Contract Research Organization (CRO) that specializes in clinical drug development research. Established in 2005 and located in Hyderabad, India, with 36,000 square feet of facility space and 150+ employees. Core Competencies: Bioavailability / bioequivalence (BA/BE) studies to support new and generic drug registrations for Drug Controller General of India (DCGI) , US Food and Drug Administration (US FDA), European Medicines Association (EMA) , Therapeutic Products Directorate (TPD), World Health Organization (WHO) , and Medicines Control Council (MCC) Early Phase clinical development (Phase I → Phase IIa), including PK/PD. Late Phase clinical development (Phase III → Phase IV) studies to support new and generic drugs. Bioanalysis for small molecules using LC-MS/MS. Clinical data management, including eCRF design, data entry, query management, data cleaning, SAS programming, SDTM and ADaM datasets to meet current CDISC standards. Pharmacokinetics and biostatistics using WinNonlin and SAS. Medical writing, including study synopsis, protocol, investigator’s brochure, informed consent forms, case report forms, ICH E3 integrated clinical reports, and eCTD publication. Project Management services. Quick turnover-time to support first-to-file studies. Achievements: 25 Regulatory inspections in 10 years. # 11 successful US FDA inspections (latest in February 2018). # 02 MHRA Inspections ( 2015 & 2019) No Observation # 9 successful DCGI inspections (latest in April 2018). # 2 successful WHO inspections (latest in October 2017). # 1 successful EMA inspection (latest in April 2015). Facility: 138 beds across 4 Clinics. 7 beds Emergency unit to handle adverse events (AEs). 3 wet laboratories. 10 triple quadrupole mass spectrometer (TQMS). Over 1,000 bioanalytical, validated assays. Capacity to analyze over 250,000 samples per year. A database including over 12,000 healthy-volunteers