Qualified Person Support
Companies that manufacture/import medicines or prepare clinical trial supplies can often find that increases in demand, new ventures or unexpected changes in personnel require the services of a contract consultant QP.
The effects of a company not being able to release its product in to the market place as a result of not being able to meet the regulatory requirements could mean disaster for the profits, market share and reputation of the company.
Paul Palmer became eligible as a Qualified Person under the transitional provisions of Directive 2001/20/EC and then under the permanent provisions of Directives 2001/83/EC and 2001/82/EC. The Qualified Person services offered therefore include certification of both Commercial and Investigational Medicinal Products (IMPs).
Following an initial induction period and with regular maintenance visits to gain the relevant knowledge and experience necessary to fulfil this duty, Paul can offer short, medium or long term assistance to cover day to day release or back-up QP services. This flexibility enables your business to continue to function and your Quality staff can manage their workload effectively