Scientific Consulting, Medical Writing,
Drug Regulatory Affairs

ENTER

in designing appropriate non-clinical development programmes encompassing pharmacodynamics, pharmacokinetics, and toxicology,

Pauels Consulting can assist you

There are many non-clinical questions to be answered before a Marketing Authorization (or even a clinical trial) can be granted...

... to speed up the development process, the answers should ideally be available before the Regulators ask for.

in identifying useful experimental models if non-standard testing is required,

in identifying suitable GLP-certified CROs and maybe academic researchers to conduct the programme,

in monitoring and coordination of study phases as well as communication of the data to the authorities,

and most of all:

in identifying causes for concern before others do.