Studies

 

Clinical and toxicological studies are not only fundamental to pharmaceuticals, but increasingly become necessary in the areas of foodstuffs and cosmetics as well. These studies for the preparation of authorisation procedures require careful planning regarding not just the innumerable legal and other requirements (e.g. scientific guidelines of EMA and EFSA), but also to ensure later usability of the data obtained. We support you with the design of studies, drafting of needed agreements, discussion with ethics committees and public authorities (European Commission, EMA, BfArM (German medical products agency), EFSA) as well as with the analysis of study results and their use in advertising. For this purpose, we maintain a close cooperation with RDA Scientific Consultants GmbH and other experts. Due to our comprehensive spectrum of support, (regulatory, IP rights, defence of advertisement with study results) you can profit from our full spectrum counselling approach in any phase of the project.