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In-Vitro Diagnostics

From pre-diagnostics through regulatory approval, we provide in-vitro diagnostics development services to help rapidly develop and commercialize new and disruptive diagnostic technologies and tools. 

 

Our scientific and subject matter expertise expands and accelerates the delivery of high-quality clinical diagnostic products.

MRIGlobal offers government and commercial clients services that include assay design, assay development, analytical verification, clinical comparator testing, and clinical validation and verification through regulatory submission. We provide extensive research and product development expertise; facilities, analytical services, clinical trial site, and clinical trial services and support; and regulatory guidance to support FDA, EUA, and 510(k) submission filings.

About Diagnostics

MRIGlobal manages a variety of in-vitro diagnostics programs.

Our capabilities range from the development of cutting-edge molecular and immunological assays focused on emerging highly infectious disease to the advancement of novel, highly sensitive diagnostic assays.

Why MRIGlobal?

We offer a broad range of research and clinical laboratory services to accelerate product development and reduce time to market.

MRIGlobal has dedicated, experienced staff with expertise in molecular biology, immunology, microbiology, bioinformatics, and engineering. This includes staff expertise in diagnostic development, clinical regulatory affairs, quality management systems, and program management. Our culture of trust and integrity, in partnership with our clients, provides innovative solutions to important problems to improve people’s lives. 

Work With Us

Your challenges inspire our scientists.

We work with multiple businesses and institutions every year to help further unbiased research and innovative development.

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