EU Qualified Person (QP)
GxP Gateway features dedicated EU QP specialists who hold the necessary certifications to oversee clinical trial compliance and legal release within the European Union and the United Kingdom.
Investigational Medicinal Product (IMP) Release
We certify clinical trial batches for Phase I–III trials, ensuring compliance with EU and UK Clinical Trial Authorizations.
Technical Agreement Implementation
We develop robust Quality Technical Agreements that define clear compliance boundaries between sponsors, manufacturers, and the QP.
QP Declaration & QP Audits
GxP Gateway provides formal QP Declarations supported by comprehensive QP Audits of active substance manufacturers, ensuring full compliance with EU and UK clinical trial and marketing authorization requirements. Our certified associates verify that your global supply chain adheres to the highest GMP standards, bridging the gap between international manufacturing and European regulatory approval.
QP Oversight of Manufacturing Operations
We validates manufacturing operations through continuous monitoring of deviations, OOS investigations, and final batch disposition to support clinical trials in the EU and UK.