Newark, Del.– QPS India, a subsidiary of global contract research organization QPS Holdings, LLC, has successfully completed an unscheduled inspection by the U.S. Food and Drug Administration (FDA), further solidifying its standing as a trusted provider of regulatory-compliant research services. The five-day audit, conducted from April 21 to 25, resulted in site approval for all studies conducted at QPS India that have been submitted by sponsors for U.S. regulatory review.
The inspection focused on systems and processes, confirming QPS India’s adherence to the rigorous quality and compliance standards expected by the FDA. This marks the 46th successful regulatory inspection for the Hyderabad-based facility over the past 20 years, adding to a list that includes prior approvals by agencies such as the EMA, UK MHRA, WHO, ANVISA, NPRA, NABL, GCC, and India’s CDSCO.
“This outcome underscores QPS India’s focus on quality, compliance, and scientific integrity,” said Dr. Kumar Ramu, Senior Vice President and Managing Director of QPS India. “It comes at a 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.”
QPS India was established in 2004 and operates a state-of-the-art, 138-bed clinical unit. The facility has completed over 1,800 Phase I and bioequivalence studies and features 11 LC/MS/MS instruments supporting more than 800 developed bioanalytical methods. The company offers a full suite of services, including early- to late-phase clinical trials, bioanalytical testing, pharmacokinetic and statistical modeling, and regulatory documentation.
The company also offers specialized services in dermatology safety studies, including cumulative irritation and sensitization tests. With experience in both patient-based PK/PD studies and healthy volunteer trials, QPS India remains fully compliant with international standards such as ICH-GCP and local regulatory requirements.
QPS Holdings, based in Delaware, operates across nine global locations, including facilities in the United States, Europe, Asia, and Australia. The company provides discovery, preclinical, and clinical research services for pharmaceutical and biotechnology clients, with a portfolio that spans pharmacology, toxicology, bioanalysis, clinical trials, and cell therapy research.
The successful FDA audit strengthens QPS India’s position as a global partner for sponsors seeking high-quality, regulatory-aligned research solutions.
