电子邮件 | ema***@***.com | 获取Email |
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电子邮件 | ema***@***.com | 获取Email |
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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
总部 | Hyderabad, Telangana |
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行业 |
research |
公司 | QPS Bioserve India Pvt Ltd. |
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职位 | Dy. General Manager, Quality Assurance |
地点 | India |
http://www.linkedin.com/in/k-n-s-bhaskara-rao-1886bb27 | |
部门 | master_engineering_technical,master_information_technology |
头衔 | Dy. General Manager, Quality Assurance |
Bhaskara Rao 在 QPS Bioserve India Pvt Ltd. 担任 Dy. General Manager, Quality Assurance
Bhaskara Rao 在 QPS Bioserve India Pvt Ltd. 的职位是 Dy. General Manager, Quality Assurance
Bhaskara Rao 的电子邮件地址是 ema***@***.com
Bhaskara Rao 的电话号码是 -
Bhaskara Rao 的公司电话号码是 -
Bhaskara Rao 在 research 工作。
Bhaskara Rao 的一些同事包括Manoj Sunku、Bhaskara Rao、Bavaji Bobby、Ramesh GarideGopi Puli、。
Bhaskara Rao联系方式: 电子邮件地址:ema***@***.com 电话号码:-
Bhaskara Rao 的个人领英是:http://www.linkedin.com/in/k-n-s-bhaskara-rao-1886bb27
Bhaskara Rao 的办公地点:Hyderabad, Telangana
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