Quality

We provide and maintain a high standard of our services by working with a modern Quality Management System, based on ISO9001 concepts. Data-management, model-based analyses and simulations, reporting and communication are performed according to Standard Operating Procedures, thus ensuring integrity, traceability and reproducibility (FDA 21 CRF part 11) of the analyses. We perform our services following all relevant guidelines from regulatory agencies (FDA, EMA and PMDA).