Quality

Quality Management System

The QualityManagement System (QMS) focusonto meet customers’ needs and requirements. Ourworkprocedures and documentation follows current guidelines cGMPfor medicinal products and ISO/IEC 17025standard -“General requirements for the competence of testing and calibration laboratories” for Medical Devices.
  • Complies to cGMP and ISO/IEC 17025
  • Complies to current international pharmacopoeia specifications, such asEur. Ph., USP, and JP
  • Quality Risk Management system based on ICH Q9 and Q10.
  • All methods and equipment are validated
  • Regularly audited by customersand authorities.

GMP Certificate

Certificate of GMP compliance issued by Medical Product Agency (MPA) in Sweden.

All methods and equipment used are validated according to Standard Operating Procedures including the outcome of annual periodic reviews.

Contact us

If you need support or scientific advice, don’t hesitate to contact us!