Medical Qualification

Applications

  • Over 200 qualified projects
  • Harmonized documentation across the North American, European and Asian markets.
  • Provided documents follow the GAMP, EU GMP, ICH and FDA guidelines and regulations
  • Qualification package can be adapted to customer’s needs

Benefits of our validated standard platforms

  • Risk mitigation: many functions are already covered by the standard platform qualification
  • Quality: the standard doesn’t need to be qualified on each project
  • Time optimization: the Mikron team is focused on customer specific processes
    Contact us

    Please fill in the form below to be contacted by one of our representatives or click here to find your local contact.