As a manufacturer of in vitro diagnostics or pharmaceutical products, you need to meet the needs of your customers with quality materials and controlled fixed costs. We help you achieve the speed, sensitivity, and accuracy to meet your customers’ demands with a wide product portfolio that sets the standard for reliable performance.
Quality backed by 40+ years of diagnostics expertise.
Keep your focus one step ahead of the competition.
In the world of in vitro diagnostics, innovation is critical. You need to differentiate yourselves from your competitors by producing the best, most cutting-edge products on the market—and you need reliable partnerships to help get there.
Flexible, custom and co-development project expertise.
We offer a full spectrum of flexible contract development and contract manufacturing services to meet your technical specifications and/or custom labeling – including formulation, OEM manufacturing, enzymes and raw materials, fill & finish and more.
Manufacturing & development expertise.
Global technical service & customer support.
Dedicated business-to-business sales team.
Quality off-the-shelf and customized diagnostics products.
We believe in providing our customers with choices. That’s why we manufacture a wide variety of ready-made assays and reagents, as well as the raw materials you need to manufacture your product.
Robust quality systems & ISO certifications.
You count on exceptional quality for your products.
Quality is the foundation of your product’s success, and every point in the production process plays a critical role in delivering the highest quality standards for your finished product. When you count on exceptional quality control, precise manufacturing, and lot-to-lot consistency, you need a partner who can deliver.
Exceed expectations with built-in quality control.
Everything we manufacture is tested by highly-trained Quality Control analysts before being released to you. Our efficient and safe manufacturing environment, along with our robust quality certifications guarantee that your finished product will always meet high quality standards and responsible manufacturing requirements.
Backed by company-wide Continuous Improvement programs such as Lean Six Sigma.
ISO13485, 9001, 14001, CMDCAS, FDA Facility Registration and OHSAS 1801 certifications.
Accurate release analysis helps you formulate your final product without incoming testing.
Support & Resources
Providing you with expert support, every step of the way.
We believe in building strong partnerships – and that means being there to provide service for your needs throughout the entire manufacturing process.
Our Global Reach
Global manufacturing facilities for customers worldwide.
Customer needs are not limited by location.
The need for high-quality in vitro diagnostics extends beyond national (and even continental) boundaries. That’s why it’s critical that your capabilities extend to a wide range of customers no matter where in the world they are located.
Our reach is worldwide, so yours can be too.
With manufacturing and distribution operations in North America, Europe and Asia, we provide systems, enzymes, assays and reagents worldwide. Our contract manufacturing facilities meet stringent regulatory standards to help you deliver products on time to customers across the globe.
Expertise in REACH regulations and Global Harmonization Standards.
Supporting a diverse range of manufacturers, from small companies to top global brands.
Experienced in international shipping and import/export requirements.
Supporting you with over 40 years of diagnostics expertise.
Backed by the resources of our global parent SEKISUI Chemical Co. Ltd. and sister company SEKISUI Medical, we remain focused on contributing to the realization of healthy and enriched lifestyles for all people.
Get in Touch
Let’s work together to bring your in vitro diagnostic products to market.
Contact us to learn more about contract manufacturing for the clinical chemistry, point of care testing and coagulation markets.