Case Study 66: Investigational Device Exemption (IDE) in USA

Company Situation

The Client is a Chinese based invitro diagnostic kits manufacturer planning to launch its IVD kits for Human Papilomavirus (HPV) detection kits in USA and was seeking a partner to provide a clinical investigation strategy for the kit and support with preparation and submission of investigational device exemption (IDE) application to FDA.

GRP Solution

As US agent, GRP team in USA, with many years of experience handling similar projects with other foreign IVD manufacturers, provided the following services:

grp can support all your regulatory, clinical,quality & safety needs

Stay updated on the Latest Regulatory Information