Consulting

The ResearchDx philosophy is to provide clear, accurate guidance to the Biopharmaceutical, Biotechnology, Clinical Diagnostics and Clinical Laboratory industries.

Biopharmaceutical and Diagnostics Consulting:

ResearchDx assists clients in rapidly developing, manufacturing and commercializing diagnostic assays. ResearchDx is the only OEM Company in the diagnostics market with the ability to contract the entire development process, or any component thereof. We can design, develop, integrate, validate and transfer to manufacturing all aspects of an assay system including biomarker discovery, assay design and development, implementation as a laboratory developed test, and 510k or PMA development and approval. 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.

Primary Services:

  • Biomarker Discovery and validation
  • Contract assay development
  • Assay clinical implementation as a laboratory developed test (LDT)
  • Diagnostic regulatory approval through the PMA or 510k process
  • Consulting services, including GLP, GCP, CLIA, CAP and ISO15189 audits and licensures/accreditation
  • Contract diagnostic manufacturing
  • Sales of supporting products, including assay materials, controls and critical reagents

Healthcare / Clinical Laboratory Consulting

ResearchDx can provide complete turnkey Clinical Laboratory startup services, or alternatively, we will work with established companies to seamlessly integrate only the components you need into your current framework. ResearchDx specializes in establishing and maintaining clinical laboratory licensure and accreditation.

Company Highlight:

ResearchDx has extensive experience with the validation, clinical implementation of Next-Gen Sequencing technologies in a CLIA approved and CAP accredited environment. Ask us about your options for implementation of Next-Gen sequencing in a Clinical laboratory environment.
Email your inquiries to info@researchdx.com

International Consulting

ResearchDx has extensive experience in navigating international companies through the United States Clinical Laboratory Implementation Act (CLIA) international certification process, and College of Pathology (CAP) international accreditation process (where required).
Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories. To discuss your individual requirements, please email info@researchdx.com, or contact us.

Email your inquiries to info@researchdx.com