
QPS Bioserve India Pvt. Ltd.
Registered Office:
Plot No. 47, IDA Balanagar
Hyderabad, TS 500037 India
CIN: U85110TG2004PTC044908
Registered Office:
Plot No. 47, IDA Balanagar
Hyderabad, TS 500037 India
CIN: U85110TG2004PTC044908
138
Phase I Beds
1,800
Clinical Studies Completed
36,000
Square Feet of Lab Space
175+
Employees
QPS India
- QPS India, an American GLP/GCP-compliant Contract Research Organization (CRO) in India, providing first class full service CRO offerings, catering to all phases of drug development and recruiting healthy subjects as well as patient populations.
- QPS India was established in 2004 and is located in Hyderabad, India, with 36,000 square feet of facility space and 175+ employees.
Core Competencies
- North American standard Covid-19 safety measures in place in the lab and the clinic to protect our staff and all study subjects
- Global generic drug assay method development and validation team
- 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
- Sample receipt from any global location
- Project Management
- Dedicated, full-time Clinical Research Associates (CRA) for clinical monitoring.
- Clinical Data Management; including eCRF design, data entry, query management, data cleaning, SAS programming, SDTM and ADaM datasets to meet current CDISC standards.
- Medical writing; including study synopsis, protocol, investigator’s brochure, informed consent forms, case report forms, ICH E3 integrated clinical reports, statistics, and eCTD publication.
- Pharmacokinetics and biostatistics using WinNonlin and SAS.
- Quick turnover-time to support first-to-file studies.
- Successful recruitment of healthy volunteers and patient study subjects across numerous GCP sites.
- Ability to successfully recruit study subjects for partial-replicate and replicate designs with long washouts and ensure subject panel completion, even with stringent Covid-19 safety procedures in place.
Facility
- 138 clinic beds
- Designated ICUs (with fully inventoried crash carts) in every clinical dosing area to protect study subjects against unforeseen AEs and SAEs.
- 4 bed emergency unit to handle adverse events (AEs)
- 3 wet laboratories
- 10 LC MS/MS systems (triple quadrupole mass spectrometers – TQMS)
- Over 1,000 bioanalytical, validated assays
- Capacity to analyze over 250,000 samples per year
- On-site, access controlled pharmacy
- ISO 15189-accredited clinical laboratory
- On-site canteen for study participants’ meal preparation
- Automated temperature monitoring for freezers and refrigerators
- Dual-level power backup system for the facility
- 500 hospital network locations for patient studies in oncology, dermatology, ophthalmology, metabolism, gastroenterology, neurology, and respiratory diseases
- Study subject tracking system
- A database including over 12,000 healthy potential study subjects
Achievements
- 29 regulatory inspections in 10 years
- 11 successful US FDA inspections (latest in February 2018)
- 9 US FDA inspections with no 483s
- 6 consecutive 483-free inspections since 2014
- 9 successful DCGI inspections (latest in April 2018)
- 2 successful WHO inspections (latest in October 2017)
- 1 successful EMA inspection (latest in April 2015)
- Additional inspections by UK MHRA and NPRA
People
- Highly experienced management staff with over 200 combined years of clinical BA/BE experience.
- Highly experienced team, including GMP, GCP, GLP, and GEP areas.
Experience
- Created and executed over 1,500 generic drug study designs.
- Successfully completed over 1,600 clinical PK studies (80% of which advanced to regulatory approval).
- Submitted 800+ studies to various regulatory agencies.
- Over 200 first-to-file studies.
- Expertise in multi-drug administration routes; including oral, intravenous (IV), intramuscular (IM), subcutaneous (SC), and topical.
- Experience across a broad range of patient populations; including, CNS (Neuropsychiatry), Cardiology, Endocrinology, Gastroenterology, HIV/Infections Diseases, Nephrology, Oncology, Opthalmology, Pulmonology, etc.
- Ability to dose controlled substances at the QPS Missouri USA site, while catering to all the back end services out of QPS India.
Leadership

Kumar Ramu, Ph.D.
Sr. VP, General Manager, India