FDA Companion Diagnostics

ResearchDx can devise, manage, and coordinate all aspects in the development of a diagnostic product.

We are one of very few companies in the diagnostics market with the ability to contract the entire development process of a medical product, or any component thereof. We can design, develop, integrate, validate, and transfer to manufacturing all aspects of an assay system, including:

 

companion-diagnostics-diagram

  • Biomarker discovery
  • Assay design, development, and implementation as a LDT or IDT.
  • Data Analysis
  • PRE-IDE submissions
  • Reproducibilty site selection and coordination
  • Clinical and analytical verification and validation
  • 510k or PMA development (Abbreviate and Special 510(k) available)
  • Coordination with the FDA, Submission Assembly, and Follow-up
  • GMP manufacturing services
  • Software Documentation

 
 
 
 

We back up this capability with an onsite group of highly experienced industry professionals that are available for consulting on any aspect of the development and commercialization of diagnostics.