Capable Team. Proven Track Record.

Broad Spectrum Capabilities.

Many Corgenix employees have pharma and biotech experience, and have been involved in several small-molecule and biologic drug discovery, development, and manufacturing projects. They not only understand the needs and concerns of these teams – they understand the importance of developing a CDx that properly positions the drug for success. Being a small organization, with flexibility in our DNA, we can scale up and down quickly to address your changing needs in order to ensure your timelines can be met.

To enable CDx, Corgenix has extensive experience in all aspects of bringing an in vitro diagnostic product to market and can provide our partners with support along the entire IVD Continuum:

Product Development

  • Experienced Product Development Team
  • Technology transfer management
  • Platform agnostic: We choose platforms to meet technical, analytical, clinical and commercial needs.
  • Critical reagent development, characterization and validation

Regulatory/Clinical

  • Experience with FDA, EU Competent Authorities, Health Canada, CFDA, and other WW RAs
  • Manufacturing facilities are registered with the FDA (registration number 1721937).
  • All products are CE Marked according to the EU in Vitro Diagnostic Directive (98/79/EC).
  • Corgenix’ Authorized Representative in the EU: MT Promedt Consulting GmbH in Germany.
  • Global Clinical Trial Test Site Management

Quality

  • Robust Quality Management System (QMS) to manage RUO, IUO and IVD product strategies.
  • All products are developed under Design Control as defined by the Corgenix Quality System which complies with FDA and other international regulatory requirements.
  • Manufacturing facilities are compliant with FDA Quality System Regulations (QSR) and are certified to ISO 13485.
  • Canadian Medical Device Regulation (CMDCAS) certified

Commercial

  • GMP Manufacturing and Product Distribution in Broomfield, CO.
  • Global Reach: >40 countries
  • Customer Targets: All Clinical Lab segments
  • Integrated Operations team (Production, QC, Product Support)
  • Product Life-Cycle Management