AlthoTech Consulting Inc. Pharmaceutical and Biotechnology Clinical Consulting
Email: consulting@althotech.com;     Tel: 647 515 5314


CMC Management  •  QP Services  •  Clinical Packaging  • Regulatory Submissions


QP Services


The European Economic Area (EEA), consisting of 30 member states, a total population in excess of 500 million and a common regulatory frame work, has become a very attractive region for clinical studies. As a result, North American pharmaceutical and biotechnology companies are looking to Europe as a location for their clinical trials.  


In May 2004, the European Union (EU) implemented Clinical Trials Directive 2001/20/EC, with which companies undertaking European clinical studies must comply.  The regulatory frame-work is complex and non-EU companies who sponsor EU clinical trials must use the specialized services of a Qualified Person (QP).


Investigational Medicinal Products (IMPs) manufactured outside of the EEA for use in European trials must be imported into a European licensed facility, released by a QP and distributed to the clinic from that facility. The QP must provide a certificate of GMP compliance (to be submitted with the EU Clinical Trial Application) confirming that non-EEA facilities used have cGMP standards at least equivalent to those specified by the EU.  To confirm this, the QP typically carries out GMP audits of the supply chain (including drug substance/product manufacturers and associated testing facilities).


There are very significant costs and time factors associated with EU based QPs executing the necessary audits: expensive transatlantic travel and availability due to workload constraints. To meet the needs of companies wishing to conduct clinical trials in Europe, AlthoTech has formed an exclusive strategic alliance with a UK Licensed QP facility to reduce the cost and simplify this process.  


AlthoTech, a dedicated UK registered QP located in North America, guides companies through the process, performing the supply chain GMP audits and reviewing GMP batch documents. Following this, supplies are imported to and distributed from the UK facility.


This unique offering dramatically reduces the cost and time required for QP release relative to using European based QPs.


AlthoTech has audited the supply chain, reviewed GMP documentation, and successfully imported six different IMPs into Europe in the last two years for Phase I, II and III trials.



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In addition, AlthoTech executes QP audits for European based licensed facilities wishing to ensure that product for importation has been manufactured to EU standards.


About 20 such audits of drug substance and drug product manufacturers (both sterile and oral) have been executed in the last 2 years.