We have extensive experience in drug development and can contribute with regulatory strategies for individual studies as well as complete development programs. We have experience of communication with regulatory authorities in Europe, the US, China and Japan. We often arrange meetings with regulatory authorities for scientific advice on behalf of our clients; nationally (Sweden, Germany, the UK and others) as well as the EMA and the FDA.
For projects approaching an application for marketing authorisation we cooperate with our sister company Scandinavian Regulatory Services (SRS). Please see www.srs.se for more info!