Our courses on regulatory affairs and compliance cover the main submissions required for the development and marketing of medicinal products in Europe and the USA. These include applications for approval to conduct clinical trials, to be granted orphan product status, to market new or generic products, and to make post-marketing changes. Whether they are introductory courses for entry-level regulatory affairs and for support staff, or they are more advanced courses for more experienced staff, they provide both a training and a reference tool that is continually updated in response to developments in regulatory requirements.