Steen Ottosen ApS is working with pharmaceutical and biotech companies of all sizes from large pharmaceuticals to micro startups to shape their pharmacovigilance (drug safety) function and for larger pharmaceutical companies to streamline their operation and constantly adapt to the complex global regulatory framework.
We assist small to large pharmaceutical companies all over the world keeping medicines, vaccines and devices safe for the users and the company in compliance with regional and national regulations. Our services include medical reviews of adverse events, medical monitoring of clinical trials, signal and risk management , PSUR, DSUR, RMP, EVDAS, Eudract, SPOR etc and communication with national competent authorities. We are fully engaged in all aspects of pharmacovigilance right from full management of an internal pharmacovigilance department to individual and specialized tasks. Having expert medical staff with many years of experience in pharmacovigilance in both US and EU we are also providing support with all aspects of Qualified Person for PharmacoVigilance responsibilities at EU level and at individual member state level.