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Sourcing Inquiry Logo Corgenix

Corgenix

Regions
North America
Countries
United States
Size
n.e.
Specialty
Service category
Contract manufacturing, filling and packaging, Analytical laboratory and testing services, …
Service category
Contract manufacturing, filling and packaging, Analytical laboratory and testing services, Regulatory services - CMC writing - medical writing, Partnering/collaboration for drug dossiers, patents, drug candidates, medical technology
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Key services

Services

Partnering

 

An important part of the Corgenix business is providing contract services to the diagnostics and biotechnology industries. These contract services include:

  • Product development
  • Technology application
  • Contract manufacturing
  • Private labeling
  • Regulatory management including  preparing and filing submissions to the FDA and managing CE marking
  • Warehousing and fulfillment
  • Distribution and commercialization

 

Our expertise, strong quality system, solid infrastructure, expert staff and state of the art manufacturing facility have attracted partners from all over the world. For over twenty years we have provided contract services to large and small medical companies, universities, research institutions and government agencies.

 

Corgenix offers critical competencies within a highly regulated industry. We are committed to providing innovative and quality medical products to meet the needs of the ever-changing healthcare field and believe our vision and commitment places our company at the forefront to do so. We can develop and support products utilizing numerous diagnostic delivery platforms.

 

Our operation in Colorado is FDA registered as well as certified to ISO 13485:2003 and in full compliance with the European IVDD  for CE marking products and the Canadian standard CMDCAS.

 

As a small company, Corgenix can respond quickly to the needs of our partners and dedicate the best minds to their projects.

 

 

Approvals, Certificates, Authorisations

  • ISO 13485:2003
  • FDA

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