We provide professional assay development solutions for POCT, ELISA, CLIA, FIA, and molecular diagnostics, including antibody screening, sensitivity optimization, buffer formulatio...
Empower Global IVD Enterprises via Reliable CDMO R&D Infrastructure
Over 95% of global clinical diagnostic decisions rely on accurate IVD reagent performance. We position ourselves as your trusted full-cycle CDMO partner to mitigate risks, accelerate development, and scale your diagnostic product to global markets.
Client-Centric Custom R&D Service
Our R&D team works closely with each client’s technical team to solve bottlenecks, optimize product sensitivity/specificity, and realize customized performance targets for your target clinical application scenarios.
Data-Driven Continuous Quality Improvement
Our central QC lab implements full-process batch testing for all house-developed prototypes, including systematic stability study, performance verification, and lot-to-lot consistency checks following ISO and regulatory standards.
Over 95% of global clinical diagnostic decisions rely on accurate IVD reagent performance; we position ourselves as your trusted full-cycle CDMO R&D partner to de-risk your diagnostic product development and global market access.
Client-Centric Custom R&D Service
Our R&D team works closely with each client’s technical team to solve formulation bottlenecks, optimize product sensitivity/specificity, and realize customized performance targets for your target clinical application scenarios.
Data-driven Continuous Quality Improvement
Our central QC laboratory implements full-process batch testing for all in-house developed prototypes; we perform systematic stability study & performance re-verification for all finished R&D deliverables following ISO & regulatory standards.
Book On-site CDMO Lab Inspection & Technical Discussion
Welcome global clients to schedule on-site visit of our ISO13485 certified R&D labs, cleanroom pilot production workshop and QC verification center. Our senior R&D director will provide face-to-face technical discussion for your upcoming IVD project.
For diagnostic companies seeking to expand their portfolios without building a new manufacturing operation from the ground up, OEM IVD manufacturing and privat...
Introduction: Finding a Reliable IVD Manufacturing Company Choosing the right IVD manufacturing company is a critical decision for diagnostic brands, medica...
IVD Raw Materials Manufacturing Is Where Diagnostic Performance Begins The performance of an in vitro diagnostic assay is often discussed in terms of sensit...
Regulatory status checked on 30 September 2026 In vitro diagnostic contract manufacturing allows a diagnostics company to outsource the production of reagen...
Choosing an IVD manufacturer requires a connected assessment of product suitability, regulatory status, quality management, performance evidence, and manufactu...
For companies outsourcing the development of an in vitro diagnostic product, one of the first commercial questions is straightforward: How much does IVD CDM...