Our Regulatory Science Team links regulatory expertise to state-of-the-art science. Within regulatory science, we address a variety of topics related to PPP registration and beyond.
We believe that a sound study design including sufficient replication and randomization, professional experimental execution and a thorough and adequate statistical analysis is needed to meet the high standards for data to be used in the registration process of PPP. Together with the QAU team we work in close cooperation with our field team to meet these standards. Our services include counselling on the study design as well as providing the statistical analyses. We also offer the same services directly to our customers for the re-(evaluation) for any existing dataset or study design including (but not limited to) the following examples:
In recent years, significant resources of the Regulatory Science Team have been devoted to develop modelling strategies and suitable simulation methods in order to use these advanced techniques in the registration process for PPPs and beyond. While the term “modelling” is widely used in the regulatory context it can have quite different meanings and applications. Our services include the re-evaluation of ecotoxicological data by Benchmark-Dose-Modelling, Body Burden Modelling based on mammalian metabolism data. Another closely related service is the power analysis for (semi-) field studies based on simulation data.