Qualified Person (QP) Services
European pharmaceutical regulations mandate that every batch of medicinal products must be certified by a Qualified Person before release for distribution. This requirement applies to imported products, locally manufactured medicines, and products moving between EU member states. Without qualified personnel authorized to perform batch release, products cannot legally enter the market, regardless of manufacturing quality or market demand.
Our Qualified Person services provide experienced, regulatory-authorized professionals who certify your pharmaceutical batches meet all quality standards and regulatory requirements. Our QP team reviews manufacturing documentation and analytical certificates, verifies GDP compliance throughout storage and distribution, confirms products meet specifications and regulatory standards, assesses any deviations or out-of-specification results, and authorizes batch release only when all requirements are satisfied.
We provide QP coverage across EU member states, supporting both routine batch release and specialized situations including product imports, inter-company transfers, contract manufacturing arrangements, and other variations. Our services scale to your needs, whether you require occasional QP support or comprehensive ongoing coverage.
Qualified Person services represent the final quality gateway before your products reach patients. Our experienced QP professionals provide the regulatory certification and quality assurance your European operations require.
Contact us today to learn how our Qualified Person services can support your batch release requirements and ensure compliant distribution.
