BIOLYZR

Our founder, Marianne Scheel Fjording, comes with 25+ years of bioanalytical experience within PK assays, biomarker assays and ADA assays from pharma, biotech, and CRO. In 2016, she was nominated to join the ICH M10 working group, representing the pharma industry. Together with FDA, EMA, and other major regulatory authorities, she participated in writing the ICH M10 guideline for the bioanalysis method validation, which is now under implementation around the world. BIOLYZR offers thus a selection of services ranging from assistance on biomarker, PK assay & ADA strategies, in-house/outsourcing decisions, CRO evaluation and audits, SOP updates & reviews, training of employees, workshops, and events. BIOLYZR MISSION: We support bioanalysis excellence in all aspects of biomarker, PK & ADA assays activities through consultancy, training, events, and networking.