ISO 13485:2016 · GMP
Contract manufacturing of diagnostic kits, reagents and controls under our ISO 13485:2016 quality system, from design transfer and pilot lots to ongoing supply.
What we make
Research use only, investigational use only and IVD products, made by the team that can also develop and validate them.
Assembly, labeling and packaging of complete kits for molecular and immunoassay tests.
Reagent manufacturing with lot-to-lot consistency and stability programs.
Custom positive, negative and calibrator materials for your assay.
Custom kits made for a single laboratory’s exclusive use.
ELISA kit production, from coated plates to final assembly.
Collection kits for clinical trials and commercial testing programs.
How it works
Specify the product and transfer the design, documents and materials into our quality system.
Build and qualify pilot lots to confirm the process and product performance.
Release each lot with QC testing and a Certificate of Analysis.
Move to ongoing production with supply chain management and change control.
Why ResearchDx
Each project has a dedicated project manager and PhD-level scientists, with medical input and laboratory testing when you need it.
Our team supports design controls, process optimization and the registration and certification work that comes with taking a kit to market.
Share your assay, components, volumes and target markets, and we will scope a manufacturing plan.