US FDA OKs QPS’ Phase I unit in Hyderabad after unscheduled inspection

QPS Holding’s Indian Phase I unit has passed an inspection by the US Food and Drug Administration (FDA).

The facility — a 138-bed clinical unit in Hyderabad that supports Phase I and BA/BE studies — was given a thumbs-up by US auditors this week following an unscheduled inspection conducted last month.

The FDA’s decision marks the 46th time QPS India’s has passed an audit in the past two decades.

Kumar Ramu, senior vice president and managing director, QPS India, said, “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.”

Disease models

In a separate statement, QPS announced the expansion of its disease models portfolio to include models of metabolic dysfunction-associated steatohepatitis, ulcerative colitis, wound healing, and psoriasis.

According to the firm, the models mimic human disease, offering insights into the underlying mechanisms of the conditions and the effects of novel treatments.

Charlene Chen, head of toxicology and preclinical sciences at QPS Taiwan, said “Pharmacology studies are a critical component in the drug development plan, helping to ensure that new drugs are safe enough to be allowed to progress to First in Human clinical research trials.”

Delaware expansion

In other news, QPS announced plans to grow its Newark, Delaware, headquarters with a $16.6 million laboratory and office expansion.

The company plans to lease an additional 55,515 square feet of space, including more than 15,000 square feet of lab space, in a new building at the Delaware Technology Park. The CRO said it will add 135 new full-time positions by the end of 2027.

QPS said it has experienced significant growth in recent years, particularly in its translational medicine division, which is based in Newark. The firm said it now requires larger research and development space as its growth is expected to accelerate.

DepositPhotos/Olivier26