Qualified Person (QP) Services

Releasing your supplies into the European Union

Following the implementation of the Clinical Trials Directive 2001/20/ EC in May 2004, any companies wishing to undertake European clinical studies have to comply with a series of regulations.

A Qualified Person (QP) is required to release supplies of IMPs that have been manufactured outside the EU for use in European clinical studies. Biotec have a team of QPs available that are highly experienced in both marketed products and IMPs. We have vast experience of working with clients, particularly from North and South America, Japan and Israel, helping to facilitate the smooth transfer of importing IMPs into Europe.

As required, our QPs will conduct audits of manufacturing facilities ensuring that each batch has been manufactured in accordance with cGMP guidelines.

We will arrange the collection of your drug from the manufacturer and import the supplies into our licenced facility in the European Union. Our QPs will certify your product for use in clinical trials in Europe, in accordance with the Clinical Trials Directive 2001/20/EC. In addition we offer a QP Consultancy service offering specialist advice by telephone, e-mail or face-to-face meeting to guide you through current legislation and ensure that your trials are compliant with the EU Directive.

Key Facts:

• Six QPs on licence.
• Advise on manufacturing site selection.
• Audits of global manufacturing sites.
• Import supplies into Europe.
• Batch record review.
• QP Consultancy Service.
• IMPs and Marketed products.