We offer customized diagnostic, analytical, and OEM assay and kit development and contract GMP manufacturing for a variety of applications. We provide GMP or GLP environments to meet the needs of your project. Schedule a consultation with our research team to discuss your specific needs.

A few of the more common services we provide:

• Assays, reagents, or final kits for research, preclinical (non-clinical), or clinical studies
• Final product kits for manufacture and U.S. or global distribution
• Molecular and non-molecular IVD development
• OEM diagnostic or analytical assays, reagents, kit components, and final kits
• Certificates of Analysis (COA)
• Sample collection kits
• ISO 13485 GMP manufacturing compliant

Project Management and Scientific Support

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.

Development Capabilities

We provide a broad range of approaches for customized product and kit development. Please see our list of technology and platform capabilities.

Compliance

ResearchDx maintains manufacturing facilities and compliance with cGMP regulations as required by the Food and Drug Administration, 21 CFR part 820, for medical devices (Quality System (QS) Regulation/Medical Device Good Manufacturing Practices).

Learn more about our custom diagnostic services and consulting. For more information or to schedule a consultation, please contact us.

Our CAP/CLIA certified lab, PacificDx offers state-of-the-art facilities and expertise to meet your immediate clinical and pre-clinical needs for high-quality clinical and biopharmaceutical testing services.