Regulatory Services

Fujirebio has a successful track record of developing and delivering global regulatory clearances to bring new and novel diagnostic tests to market for Fujirebio products and those of our partners. 

Our experience includes therapeutic areas such as ovarian, lung, breast, and pancreatic cancers, as well as infectious disease, neurology, and cardiology. This experience enables the development of robust test indications and substantive support to regulatory agencies. 

Fujirebio has experience across various regulatory pathways which include registration in the US and global markets.  Experience in the US market includes, the Breakthrough Device Program, Humanitarian Device Exemption Program, and the De Novo 510(k) programs. 

Our teams have full program, project, and document management capabilities to comply with FDA Design Controls (21 CFR 820.30) and Risk Management (ISO 14971:2019). 

Fujirebio is actively involved in standard development organizations, such as the Clinical and Laboratory Standards Institute (CLSI), to ensure current state of the art analytical test validation designs.

 

Back to Contract Development/Manufacturing Organization (CDMO)

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