The inspection was a systems and processes audit resulting in the site approval for all studies conducted at QPS India and submitted by sponsors for US regulatory agency approval
QPS India, a subsidiary of QPS Holdings, a GLP/GCP-compliant global full-service Contract Research Organization, has achieved another significant milestone by completing an unscheduled inspection by the US Food and Drug Administration (FDA) from April 21 to 25, 2025. The inspection was a systems and processes audit resulting in the site approval for all studies conducted at QPS India and submitted by sponsors for US regulatory agency approval.
The 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 rigour.
“This outcome underscores QPS India’s focus on quality, compliance, and scientific integrity. It comes at the perfect time as we introduce specialised 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 and Managing Director, QPS India.
