We offer customized GMP manufacturing kit development, including diagnostic, analytical, and OEM assay and and contract manufacturing for a variety of applications. We provide ISO 13485:2016 or GMP environments to meet the needs of your project.
ResearchDx strictly monitors the process from development to production of the reagents, and analyzes the performance indicators of the antibodies/antigens to ensure the difference between batches, stability and sensitivity of the reagents.
ResearchDx offers multiple solutions for diagnostic packaging. Our healthcare expertise spans across the spectrum of diagnostics, giving you a competitive advantage. With a clear focus on quality, material knowledge, and end use, we’re an essential partner for your diagnostic packaging.
Have a complex LDT that would benefit from being manufactured in kit form. RDx can manufacture, qualify and QC all reagents, controls and materials, and provide your clinical laboratory a ISO-13485 approved kit for your exclusive use.
We offer a comprehensive solutions for custom Enzyme-Linked Immunosorbent Assay (ELISA) kit development. We work closely with you to industrialize production conforming to ISO 13485, tailoring kits to your specific requirements. Whether for biomarker detection, disease diagnosis, or drug screening, the customized ELISA kits we produce provide robust and sensitive target analyte detection.
We help you enhance cell culture processes, improve antibody purification strategies, and optimize buffer preparation to save time and increase productivity.
ResearchDx has unparalleled experience with US and international certification regulations and the requirements of the global import and export trade, to help your product certification and export.