A surgical device manufacturer pursued their first 510(k) clearance for their CE-marked product but was faced with considerable challenges during the FDA review process.

Successfully developing a medical device or combination product in the preclinical stage requires the right resources and guidance combined with quality delivery and optimal scientific knowledge and capabilities.

Meet your regulatory obligations with high-quality data and expert insights.

Labcorp discovery oncology offers hundreds of cell line growth curves in our complete cell line list.

A mid-sized biotech sponsor developing novel autologous and allogeneic CAR T therapies engaged Labcorp to support several solid tumor and hematologic malignancy therapeutic programs.

From preclinical research through clinical development, we're here to help you at every stage of the continuum to deliver accurate, on-time results and advance your program. To meet your program's requirements, our GLP, nonproprietary methods have been developed according to FDA Crystal City and current regulatory guidelines.

WC12 2023 -- Cardiovascular disease is the leading cause of death worldwide; however, no regulatory assays are currently available to predict drug/chemical-linked effects on atherosclerosis (an inflammatory process involving a series of progressive cellular events, including monocyte adhesion to the luminal endothelial surface).

Pulmonary fibrosis is a progressive interstitial lung disease characterized by increased deposition of extra cellular matrix and scarring of lung tissue over an extended period of time.

Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease characterized by increased deposition of extra cellular matrix and scarring of lung tissue over an extended period of time. The deposition of extra cellular matrix and scarring leads to a decline in lung function which is ultimately fatal.