QPS India Successfully Completes US FDA Regulatory Inspection, Marking 46th Regulatory Approval
Key Insights
QPS India (search), a subsidiary of QPS Holdings (search), successfully completed an unscheduled US FDA inspection from April 21-25, 2025, resulting in site approval for all studies submitted for US regulatory agency approval.
The milestone marks QPS India (search)'s 46th successful regulatory inspection over two decades, reinforcing its commitment to quality standards and scientific integrity in clinical research services.
The approval comes as QPS India (search) introduces specialized dermal safety services, positioning the company as a reliable partner for regulatory-driven research with its 138-bed clinical unit and comprehensive bioanalytical capabilities.
QPS India (search), a subsidiary of global Contract Research Organization QPS Holdings, has successfully completed an unscheduled week-long inspection by the US Food and Drug Administration (search) (FDA) conducted from April 21 to 25, 2025. The systems and processes audit resulted in site approval for all studies conducted at QPS India and submitted by sponsors for US regulatory agency approval.
This achievement marks the 46th successful regulatory inspection for QPS India (search) over the past two decades, following previous audits by major global regulatory bodies including the US FDA, European Medicines Agency (search) (EMA), UK Medicines and Healthcare products Regulatory Agency (search) (MHRA), World Health Organization (WHO), and others.
"This outcome underscores QPS India (search)'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, Senior Vice President and Managing Director of QPS India.
Facility Capabilities and Service Offerings
Established in Hyderabad in 2004, QPS India (search) operates a state-of-the-art 138-bed clinical unit that has completed more than 1,800 Phase I and bioavailability/bioequivalence (BA/BE) studies. The facility is equipped with 11 LC/MS/MS instruments for bioanalysis and has developed over 800 bioanalytical methods to date.
The company provides comprehensive clinical research services including:
- Clinical trials from Phase I to Phase IV
- Pharmacokinetic/Pharmacodynamic (PK/PD) studies in patient populations
- Specialized dermatology safety studies including Skin Irritation (Cumulative Irritation Patch Test - CIPT) and Sensitization (Human Repeat Insult Patch Test – HRIPT)
- Advanced bioanalytical services
- Medical writing for regulatory documentation
- Clinical data management
- Pharmacokinetics and statistical analysis for regulatory submissions
Global Research Network
QPS India (search) is part of QPS Holdings (search)' global network spanning nine locations worldwide, including facilities in the United States (Delaware, Miami, and Missouri), Europe (Austria and The Netherlands), Asia (Taiwan, China, and India), and Australia (Melbourne).
The parent company, QPS Holdings (search), has been providing discovery, preclinical, bioanalysis, and clinical research services to pharmaceutical and biotech clients for 30 years, employing over 1,100 staff globally.
Regulatory Excellence
The successful FDA inspection reinforces QPS India (search)'s adherence to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards. The company has maintained a consistent track record of regulatory compliance with successful submissions to global authorities including the FDA and EMA.
This latest approval further strengthens QPS India (search)'s position in the competitive contract research landscape, particularly as it expands its specialized services in dermatological safety testing, an area of growing importance in pharmaceutical and cosmetic product development.
For pharmaceutical sponsors conducting clinical trials in India, this regulatory milestone provides additional confidence in QPS India (search)'s ability to generate high-quality data that meets stringent international regulatory requirements.