Qualified Person Services

Products 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 EU 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.

The rules are complex and the responsibility of the QP is growing. We can advise on the proper interpretation of these rules for your project.

We can help you to develop the quality systems you need to establish your own authorisations for the importation or supply of commercial and investigational products.

Eligible 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.