Qualified Person Services
Streamlining Logistics Across Europe
Brexit introduced new challenges to conducting clinical trials in the European Union (EU) and the United Kingdom (UK). CalCog provides Qualified Person (QP) services and Qualified Person (QP) oversight services to efficiently manage the importation of Investigational Medicinal Products (IMPs) and other drug products into the EU and UK.
Simplifying EU and UK Drug Product Logistics
Our QP services help you to rise to the post-Brexit challenge of moving IMP or other drug product through Europe, adhering to the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) regulations.
Leveraging the required Manufacturing and Import Authorisation licences, CalCog supports importing and distributing your medicinal products in the UK or EU.
Our QPs manage batch certification and release of IMP for use in clinical trials, Expanded Access Program drug product, and commercial products for use as comparators, rescue medications, or co-medications.
Qualified Person Services
CalCog’s expert QPs accept personal and legal responsibility as EMA and MHRA regulations require.
Ultimately, our QPs ensure that the medicinal products they release into the EU and UK clinical trial supply chains have been processed under GMP conditions and manufactured in compliance with the requirements of their clinical trial authorizations.
The following offers a more detailed look at CalCog’s QP Services.
Active investigational substances for medicinal products for human and veterinary use require a document by a QP confirming the substance has been manufactured per Good Manufacturing Practice (GMP).
QP Batch Certification/Release
Product for human and veterinary use requires a certification of the batch performed by a QP, signifying that the batch has been manufactured in accordance with Good Manufacturing Practice (GMP) and checked to ensure compliance with the regulations within the jurisdiction where certification takes place.
QP Oversight Services (UK)
IMPs imported into Great Britain from countries on an ‘approved country for import’ list (all EU and EEA countries) require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to assure the IMPs have been certified by a Qualified Person (QP) in a listed country.
QP Audit Services
Onsite and remote audit services to ensure investigational materials have been manufactured in accordance with Good Manufacturing Practice (GMP).
Years Supporting Clinical Programs
QP Releases Annually
Active Programs Annually
Global Shipments Annually
Do You Need Qualified Person Services?
If you need assistance releasing medicinal products into the EU or UK, we’re here to help.