NNOVATION DECLARATION

Provide innovative medical device application services for domestic and foreign enterprises engaged in the development of innovative IVD products (reagents, instruments, software), covering innovation policy consultation, innovation regulation training, novelty/creativity assessment, product formulation guidance, clinical value assessment, data writing guidance, expert meeting guidance, etc. Help products enter the NMPA Innovative Medical Device Special Review or FDA Breakthrough review process.

ADVANTAGESRich experience

We have consulting experience in 7 innovative medical device products in the IVD field, which is the best foundation and wealth to provide good service for your enterprise.

Professional accumulation

We specialize in CRO services in the IVD sector, with a deep understanding of the technical and clinical applications of each type of product, as well as the perspective of regulations, processes and regulatory regimes.