QP Services

Following the implementation of the Clinical Trials Directive 2001/20/EC in May 2004, a Qualified Person (QP) is required to release supplies of IMPs that are to be used in European clinical studies but have been manufactured outside the EU. Biotec have a team of 5 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.

Our QPs will conduct audits of manufacturing facilities and advise on manufacturing site selection.

We will arrange the collection of your drug from the manufacturer and import the supplies into our licenced facility in the European Union.

Our QP’s 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.