QPS India has achieved another significant milestone by successfully completing a scheduled inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) from the 25th to the 29th of November 2024. The inspection was a systems & processes audit resulting in the site approval (valid for at least next 2 years) for all studies conducted at QPS India and submitted by sponsors for UK regulatory agency approval. Dr. Ramu, Sr. Vice President & Managing Director, QPS India states:
“This approval reinforces QPS India’s unwavering commitment to the highest standards of quality, compliance, and scientific rigor. It is a testament to the exceptional dedication and expertise of our team, who consistently ensure that we exceed global regulatory expectationsโ
This accomplishment represents the 44 successful regulatory inspection for QPS India by esteemed authorities, including the US FDA, EMA, WHO, GCC, ANVISA, NPRA, NABL, and CDSCO, over the past 20 years. QPS India continues to build on its legacy as a trusted partner for pharmaceutical and biopharmaceutical companies globally with adherence to timelines and delivering regulatory-compliant research solutions with precision and integrity.
QPS India, established in Hyderabad in 2004, is a subsidiary of QPS Holdings, LLC, a GLP/GCP-compliant global full-service CRO providing discovery, preclinical, bioanalysis, and clinical research services to pharma and biotech clients for the past 30 years. With a robust presence across 9 locations worldwide, including the USA (Delaware – Headquarters, Miami & Missouri), Europe (Austria & The Netherlands), Asia (Taiwan & India), and Australia (Melbourne). QPS accelerates pharmaceutical breakthroughs by delivering custom-built research services in Pharmacology, Toxicology, DMPK, Bioanalysis, Translational Medicine, Leukopaks and Cell Therapy Products, Clinical Trials, and Clinical Development.
Key Highlights of QPS India:
Comprehensive Clinical Services: End-to-end support for clinical research
- Clinical Services: Phase I to Phase IV studies
- Bioanalytical Services: Advanced analysis using cutting-edge technology
- Medical Writing: High-quality documentation for regulatory compliance
- Clinical Data Management: Efficient handling of clinical data
- Pharmacokinetics and Statistical Analysis: Expert modeling and interpretation
- Quality Assurance and Regulatory Support: Ensuring compliance with global standards
Extensive Regulatory Compliance
- 44 successfully completed inspections over the last 20 years
- MHRA, US FDA, EMA, WHO, GCC, ANVISA, NPRA, NABL, and CDSCO
State-of-the-Art Facility:
- 138 bed clinical capacity
- 1,800+ Phase I and BA/BE studies completed
- 11 LC/MS/MS instruments for bioanalysis
- 800+ bioanalytical methods developed
- PK/PD studies in patient populations
- Pharmacoscintigraphy expertise
ABOUT QPS HOLDINGS, LLC
QPS is a global, full-service, GLP/GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, bioanalysis, preclinical and clinical drug development services. Since 1995, QPS has grown from a small bioanalysis shop into a full-service CRO with 1,100+ employees in the US, Europe, and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in pharmacology, DMPK, toxicology, bioanalysis, translational medicine, leukopaks and cell therapy products, clinical trials, and clinical research services. An award-winning leader focused on bioanalysis and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction, and turnkey laboratories and facilities. Through continual enhancements in capacities and resources, QPS stands tall in its commitment to delivering superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com or email info@qps.com.
QPS CONTACT:
Contact: Gabrielle Pastore, QPS
Phone: 1-302-635-4290
Email: gabrielle.pastore@qps.com