Pauels Consulting
Scientific Consulting, Medical Writing,
Drug Regulatory Affairs
http:// http:// http://

Office Steinfurt
Alleestr. 18
D-48565 Steinfurt
Phone: +49-(0)2552-9972-00
Fax:     +49-(0)2552-9971-99

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in designing appropriate non-clinical development programmes encompassing pharmacodynamics, pharmacokinetics, and toxicology,
Pauels Consulting can assist you

Scientific Consulting
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 preparing regulatory/scientific advice meetings with the relevant authorities,
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.