Preclinical phase

Initial concept

An intelligent preclinical development concept is a prerequisite for selecting suitable tests for obtaining precise information about the pharmacodynamics, pharmacokinetics and toxicology of your active substance. We also clarify whether or not preclinical investigations are necessary in the event of changes to the route of synthesis and other modifications.

For veterinary medicinal products, early planning and analysis of Maximum Residue Limits (MRLs) as well as ecotoxicological assessments are highly recommended.

Coordination with the regulatory authorities

We coordinate the preclinical concept with the regulatory authority within the framework of scientific advice discussions. To this end we prepare the necessary background documentation and questionnaires, schedule meetings and prepare meeting minutes.

Practical implementation

We find the right partners to carry out the necessary investigations.