All aspects of laboratory services are performed in accordance with international Good Clinical Practice (GCP) and Good Clinical Laboratory Practices (GCLP) standards. We are accredited by the College of American Pathologist (CAP) and have obtained CLIA (Clinical Laboratory Improvement Amendments) ISO9001 and ISO13485 certifications. Our laboratory information management system complies with FDA 21 CFR part 11 regulations.
Nordic Bioscience’s manufacturing division produces our unique biomarkers in compliance with GMP regulations, ensuring high quality biomarkers with traceability and reproducibility. Our biomarkers are validated according to European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines to ensure analytical and clinical validity.
All manufacturing and laboratory activities are closely monitored by an independent quality management team, and any study-related deviations are reported back to our customer to ensure transparency. In addition, our laboratory undergoes annual external audits by various auditors from our customers and accreditation bodies. These audits enable us to continuously improve and renew our laboratory services to meet the latest regulatory requirements.
