Our Capabilities
- Biomarker and technology feasibility evaluation
- Assay optimization and reagent formulation including dry chemistry solutions
- Sample processing and cartridge‑integrated workflow development
- Analytical verification and performance characterization
- Reagent stability studies and documentation for future scale‑up
We cover multiple assay technologies from molecular assays to immunoassays (plate-based and LF-formats; molecular labels and nanoparticles).
Consulting support can be added at any stage to guide study design, acceptance criteria, and regulatory alignment.
Accelerating innovation
Selecting a contract design and manufacturing partner is a critical decision—one that influences quality, regulatory compliance, scalability, and ultimately speed‑to‑market.
Uniogen brings together decades of multidisciplinary expertise in diagnostics, biomaterials, engineering, automation, and regulated manufacturing to help customers transform ideas into certifiable, manufacturable products. We support companies that need a partner who is not only technically strong, but also collaborative, flexible, and able to navigate demanding regulatory landscapes. We have strong regulatory understanding including ISO 13485, ISO 14971 and CE-IVDR.
Custom biomolecule conjugation
Customizable conjugation of reporters or binders with variable chemistries
