ISO 13485:2016 · GMP · Custom kits
Custom diagnostic kit development and contract manufacturing — diagnostic, analytical, and OEM assays, reagents, controls, and final kits built to your requirements.
A strategic manufacturing partner
We offer customized GMP kit development and contract manufacturing for diagnostic, analytical, and OEM applications, in ISO 13485:2016 or GMP environments to fit your project.
Every project has a dedicated project manager and is designed by experienced PhD-level scientists, with medical input as needed and analytical or clinical testing to meet quality and regulatory requirements.
Licensed to manufacture and supply consumables for the life sciences sector.
Experienced in working with diagnostic kit makers to create products for their specific needs.
High-quality products ready for delivery — often less costly than building in-house manufacturing.
Manufacturing services
We monitor development through production and assess antibody and antigen performance to control lot-to-lot variation, stability, and sensitivity.
Diagnostic packaging solutions built on material knowledge, end use, and a clear focus on quality.
Turn a complex LDT into a kit: we manufacture, qualify, and QC all reagents, controls, and materials for your laboratory’s exclusive use.
Custom ELISA kits industrialized under ISO 13485 for biomarker detection, disease diagnosis, or drug screening.
Improve cell culture, antibody purification, and buffer preparation to save time and increase productivity.
Support with US and international certification and import and export requirements for your product.
How a project runs
Define components, specifications, and quality requirements, and transfer the design into manufacturing.
Build and qualify initial lots, including reagents, controls, and packaging.
QC testing and Certificates of Analysis for each lot.
Ongoing production, supply chain management, and process improvement.
Tell us about your assay, components, volumes, and target markets.
Every project is tailored to your needs, schedule, and quality requirements.