The EU Clinical Trials Directive requires all non-EU manufacturers of Investigational Medicinal Products to be audited for compliance with Good Manufacturing Practice. Each batch must be certified by a Qualified Person on importation into the EU.
Somerset House Consultants has successfully carried out these services for a number of US-based clients over the past year. The projects have included conventional sterile and non-sterile products and biotechnology products.
Somerset House Consultants helps pharmaceutical companies worldwide to select, audit and manage contractors for their outsourced development and manufacturing projects.
We provide quality assurance and Qualified Person release services for API, IMP and marketed products.
Our expert consultants ensure that work is carried out on-time, on-budget and in compliance with all current Good Manufacturing Practice requirements.
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