Strategic Manufacturing Partnership: Developing Custom Diagnostic Kits to Meet Your Precise Requirements
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.
Reagent Manufacturing
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.
Kits Assembly and Packaging
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.
Custom LDT Kit Manufacture
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.
ELISA Kit Production Services
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.
Process Optimization
We help you enhance cell culture processes, improve antibody purification strategies, and optimize buffer preparation to save time and increase productivity.
Registration and Certification
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.
Manufacturing Capabilities
- Assays, reagents, or final kits for research, preclinical (non-clinical), or clinical studies
- Custom Controls for any application
- Customized regulatory expertise
- Turnkey manufacturing solutions
- Process improvement support
- Supply chain management
- OEM diagnostic or analytical assays, reagents, kit components, and final kits
- Sample collection kits
- ISO 13485:2016 GMP manufacturing compliant
The RDx Difference
- High availability: High-quality products readily available for delivery to the customer’s site
- ISO 13485 certified: Licensed to manufacture and supply consumables for the life sciences sector
- Expertise in custom kit creation: Experienced in working with diagnostic kit manufacturers to create custom products for their specific needs
- High value and cost effective: We are less expensive than you would believe. In the majority of cases cases it’s cheaper to outsource your kit production than to manufacture inhouse.
Every project is tailored to your needs and has a dedicated project manager to guide and ensure your project stays on target with your goals and schedule. All projects are evaluated and designed by experienced PhD-level scientists with input from medical experts as needed. All development projects undergo analytical or clinical testing as required to meet quality and regulatory requirements, and/or the needs of the project.