All aspects of our laboratory services are performed in accordance with international Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards. Our facility is accredited by the College of American Pathologists (CAP) and is ISO9001 certified. We have been CAP-accredited since 2010, and gained our ISO9001 certificate in 1996 and ISO 13485 in 2016. Our laboratory information management system supports compliance with FDA 21 CFR Part 11. All laboratory activities are closely monitored by an independent quality assurance team, and all study-related deviations are reported back to our customers for transparency.
Nordic Bioscience's IVD Manufacturing Division produces high-quality biomarkers under GMP regulations (ISO13485 certified) with traceability and strong reproducibility. In addition, we provide advanced biomarker validation and support for customers requiring validation according to FDA and EMA guidelines and platforms that enable highly accurate data.
Please don't hesitate to contact us if you have any questions or other inquiries.