QP Facilitation Program

Simplifying the QP process

Our QP Facilitation Program is designed to provide the necessary background information on how the QP release process occurs. The program happens on-site and enables us to gather much of the documentation required for the import and release of investigational medicinal products into the EU. An experienced Quality Compliance Manager will work side by side with you for approximately 2-3 days. This process, which normally takes place via email or phone over an extended number of weeks, is simplified and expedited with our on-site guidance. Achievable goals and contact points will be agreed upon in advance of the trip, with a performance status report issued upon leaving the site.

Key benefits you will receive:

• Step-by-step review of the QP process
• Review of why QP services and release is required
• Open forum to answer any questions around QP release
• Collection of relevant documentation
• Early completion of necessary forms
• Establish relationships with relevant personnel

Onsite services help to improve understanding of your processes, as well as allows us to supplement any lack of internal resources. Your documentation is completed early, ultimately removing the preparation for QP release from the critical path prior to IMP distribution.