The Complete CDMO Package
Our competence to supply IVD raw materials and develop novel biomarkers, uniquely positions us in the market as the primary content provider to the diagnostics industry. Fujirebio offers diagnostic companies a comprehensive range of products and services from “raw material to finished product”:
Critical Raw Materials Manufacturing
We develop and manufacture core materials and antibodies and have the capacity to supply them at scale anywhere in the world. High quality is guaranteed by state-of-the-art GMP manufacturing facilities, ISO certifications, a mature quality system, and the application of the same materials across multiple technologies..
Customization and Co-Development
We develop core materials ourselves and have the expertise to customize solutions to the technology needs of our customers. Our experts are ready to help and work together with GDMOs to develop the markers of tomorrow, customized to their platform. We have a proven track record of developing assays and providing a level of regulatory consultation that ensures marketability.
Production on a Global Scale
Beyond our assay development competence, we also mass produce the relevant product at global market scale. Our GMP manufacturing sites strategically placed around the world guarantee consistency of both quality, supply and on-time delivery wherever needed.
Auditing
Our global footprint allows us to meet both the internal quality standards of our partners and the requirements of national or regional regulatory bodies with regard to manufacturing and product quality standards.
Continuous Development
On our own and in partnership with global researchers, we continue to develop new markers which will add value to the clinical management of patients. Access to these new markers helps our partners refresh and expand their product portfolios more rapidly and efficiently. We develop long term partnerships based on the shared desire to meet the world’s ever-changing clinical needs.
More Information About Our CDMO Capabilities:
OEM Custom Solutions at Fujirebio Diagnostics Inc.
Fujirebio Diagnostics Inc. provides a comprehensive array of human and animal serum products to the scientific community.
We have the capability to manufacture small and large batch serum-based matrix preparations; and we offer contract manufacturing for high-quality, in vitro diagnostic controls, calibrators, and reagents.
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We strive to provide a complete “raw material to finished product” approach to fulfill our customers’ needs. We are able to assist in the choice of matrix, treatment, testing, filling, labeling, and packaging specifications. Specially selected serum sources, in addition to unique customer requirements, enable customized solutions to your base matrix needs.
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Our commitment to quality and our determination to offer affordable products, coupled with on-time delivery, has afforded us many long-term customer relationships. Our specialty is the ability to offer niche products unavailable from other bulk manufacturers.
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Fujirebio Diagnostics, Inc.’s competencies are enhanced by our quality certification in ISO 13485. We are FDA registered as a manufacturer and contract manufacturer and comply with the requirements of the FDA’s Quality System Regulations 21CFR820.
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Our experience in the Chemistry and Immunoassay Control markets includes fertility and thyroid hormones, glucose, glycated and non-glycated hemoglobin products in the in-vitro diagnostics market, including Point-of-Care Testing and Over-the-Counter device controls.
Fujirebio Diagnostics has a history of long-term partnerships with its clients, built on its reputation, providing the highest quality products at competitive prices.
