Consulting, Medical Writing,
Drug Regulatory Affairs
Pauels Consulting 2008
appropriate non-clinical development programmes
pharmacodynamics, pharmacokinetics, and toxicology,
Consulting can assist you
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.
preparing regulatory/scientific advice meetings with
the relevant authorities,
identifying useful experimental models if non-standard testing is
identifying suitable GLP-certified CROs and maybe academic researchers
to conduct the programme,
monitoring and coordination of study phases as well as communication
of the data to the authorities,
and most of
in identifying causes for concern before others do.