Current Edition

Working with the Regulators

Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role is not to make life for drug developers difficult, as they are stakeholders in the development process, responsible for ensuring the safety and efficacy of new medicines. Bruno Speder at SGS Clinical Research explains why early and frequent consultations with the regulators by pharma companies and their clinical research organisations (CROs) and contract manufacturing organisations (CMOs) will make the path to market smoother.