QP Services
QP Services
In the EU and UK, Investigational Medicinal Products (IMPs) cannot be released to clinical trial sites until they have been certified by a Qualified Person (QP). At QCS, we recognise the critical role QPs play in ensuring compliance with regulatory standards and maintaining the highest quality in clinical trials.
Dedicated QP for Each Project: We assign a dedicated QP to each project, collaborating closely with you to ensure thorough project setup and meticulous execution. This personalized approach fosters long-term relationships with our partners.
Deep Industry Knowledge: Our QPs possess deep industry knowledge and understand the specific clinical trial requirements within the EU and UK.
Importation Compliance: For IMP importation within the UK and EU, our QPs take personal responsibility to complete the IMP QP Declaration, confirming compliance with GMP standards equivalent to EU GMP.
Our QPs provide comprehensive support and advice throughout the clinical trial process:
Supply Chain Map Review: We assess and optimise the supply chain to enhance efficiency.
Importation Setup: Our team sets up the importation process for Investigational Medicinal Drugs into the UK and EU.
Manufacturing and Testing Site Audits: Rigorous audits ensure compliance and quality.
QP Declaration for Importation: We handle the necessary declarations for IMP import.
Clinical Trial Authorization Application Review: Expert guidance during the authorization process.
QP Certification of Finished Supplies: Ensuring compliance before distribution to clinical sites.
QP Oversight for Import in the UK: Monitoring and Quality Assurance.
Product Specification File Setup: Advising on setup for regulatory compliance.
For all your QP requirements, feel free to contact our dedicated team today. We’re here to assist you in ensuring the success of your clinical trials. 🌟