Our quality systems and regulatory expertise combined with a full range of custom and contract manufacturing services provide a global solution for the diagnostics industry with a focus on customer satisfaction. We are proud to partner with the world’s largest diagnostics manufacturers as well as helping new diagnostics companies navigate compliance requirements and launch the products that will transform healthcare. We offer a comprehensive array of services to meet the development and production needs of medical device manufacturers and diagnostic organizations worldwide.
Quality & Regulatory Management, ISO Certifications, and more...
Brochure: Contract Manufacturing Capabilities
Tech Article: Is your clinical diagnostics contract manufacturer prepared to weather supply chain challenges?
Tech Article: Complete Solutions for IVD Chemiluminescent Immunoassay (CLIA/CLEIA) Development
Tech Article: Complete Solutions for PCR Assay Development
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Image 1.Key technologies we offer for diagnostic assay OEM and Contract Manufacturing Services
We offer extensive expertise in many technologies needed to successfully commercialize medical devices and IVD assays.
We have extensive manufacturing capabilities with a secure supply-chain and global footprint to give you the reliability, consistency, and flexibility to meet your needs.
Image 2.QC testing analysis for an OEM or Contract Manufacturing Services for diagnostic assay
Our analysis capabilities include:
Molecular - qPCR, PCR, western blotting, Southern blotting, electrophoresis, nuclease contamination, bacterial growth, cell component isolation kits (DNA, RNA, protein)
Immunological - ELISA, western blotting, Ouchterlony double diffusion, cell staining, histology, serology
Functional - Plasmid purification, cloning, protein depletion, proximity ligation assays (Duolink®)
Other specialized analyses
We are an industry leader for complex manufacturing our quality systems are designed to meet stringent regulatory requirements including:
Our global footprint includes 21 ISO 13485 manufacturing sites.
Image 3.NA and EMEA manufacturing sites for diagnostic assay components
Our dedicated project managers are scientists who understand the technical, operational, and regulatory challenges of our client’s projects. For each client, we offer:
Inquiry and Consultation
After receiving your inquiry, you will be contacted by one of our Business Development Specialists.
Project specifications are reviewed internally to determine feasibility and costing. Quote for project sent to you.
Creation of Project Team/Implementation
A cross-functional project team is assembled with expertise specific to project. Small-scale validation batched produced.
We manufacture at scale to your specifications with your custom packaging/labeling for regional or global distribution.
Research. Development. Production.
We are a leading supplier to the global Life Science industry with solutions and services for research, biotechnology development and production, and pharmaceutical drug therapy development and production.