QPS India Successfully Completes Week-Long US FDA Regulatory Inspection

QPS India, a subsidiary of QPS Holdings, LLC (QPS), a GLP/GCP-compliant global full-service Contract Research Organization, has achieved another significant milestone by successfully completing an unscheduled inspection by the US Food and Drug Administration (FDA) from the 21st to the 25th of April 2025. The inspection was a systems & processes audit resulting in the site approval for all studies conducted at QPS India and submitted by sponsors for US regulatory agency approval. This approval marks the 46th successful regulatory inspection for QPS India over the past two decades, including previous audits by the US FDA, EMA, UK MHRA, WHO, ANVISA, NPRA, NABL, GCC, and CDSCO, and reinforces QPS India's unwavering commitment to the highest standards of quality, compliance, and scientific rigor.

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Kumar Ramu, Senior Vice President & Managing Director, QPS India.

“This outcome underscores QPS India’s focus on quality, compliance, and scientific integrity. It comes at the perfect time as we introduce specialized dermal safety services for our global clients. Our team’s unwavering efforts continue to position us as a reliable partner for regulatory-driven, high-quality research, said Dr. Kumar Ramu, Sr. Vice President & Managing Director, QPS India.

QPS India: Key Highlights

State-of-the-Art Facility:

• 138-bed clinical unit, with 1,800+ Phase I and BA/BE studies completed
• PK/PD studies in patient populations
• 11 LC/MS/MS instruments for bioanalysis, with 800+ bioanalytical methods developed

Comprehensive Clinical Services: End-to-end support for clinical research

• Clinical Services: Phase I to Phase IV studies
  • Fully compliant with global standards, including ICH-GCP and local regulatory requirements
• Dermatology Safety Study Expertise
  • Skin Irritation (Cumulative Irritation Patch Test - CIPT) studies
  • Sensitization (Human Repeat Insult Patch Test – HRIPT) 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: Robust statistical models on comparative trials for FDA and EMA submissions
• Quality Assurance and Regulatory Support: Proven track record with successful submissions to global regulatory authorities (including FDA and EMA)

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, China & 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 Research Services.

ABOUT QPS HOLDINGS, LLC

QPS is a global, full-service, GLP/GCP-compliant contract research organization (CRO). Over the last 30 years, QPS has grown from a small bioanalysis shop into a full-service CRO with 1,100+ employees and a robust presence across 9 locations worldwide, including the USA, Europe, Asia, and Australia. 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. For more information, visit www.qps.com or email info@qps.com.

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