From safety evaluation to market approval,
without the usual 18-month wait

A cardiovascular device developer needed a nonclinical safety evaluation pathway recognized by both FDA and NMPA — and wanted a way to reduce reliance on animal testing without compromising rigor or timelines.

We combined organ-chip-based biocompatibility prescreening with our integrated GLP system, so biocompatibility evaluation, safety evaluation, durability testing, and CMC documentation were handled under one platform instead of being coordinated across multiple separate vendors.

The nonclinical evaluation phase completed in 12 months, against an industry benchmark of 15–18 months — with meaningfully lower cost from reduced duplicate testing and fewer vendor handoffs. The product went on to receive NMPA registration on its first submission.

Figures reflect an anonymized platform engagement, shared with client consent under our standard confidentiality practice. Specific client identity, product details, and commercial terms are withheld.