Qualified Person Services
manufactured or sold within the European Union or used in most clinical studies
in Europe must be
certified by a
Qualified Person prior to their release. The
rules are set out in
Directives 2001/83/EC and 2001/20/EC, and in
Eudralex Volume 4. Further guidance specific to the UK is to be found in the
Code of Practice for QPs.
rules are complex and the responsibility of the QP is growing. We can
advise on the proper interpretation
of these rules
for your project.
help you to develop the quality systems you need to establish your own
authorisations for the
importation or supply
of commercial and investigational
under the permanent provisions of Directive 2001/83/EC, our experts can serve as
the GMP Qualified Person on your Manufacturer's/Importer's Authorisation.
Contact us at e-mail :