Qualified Persons

All of our oprations are controlled within a formal documented quality management system in accordance with:

• The European Clinical Trials Directive (2001/20/EC)
• Annex 13 of the EU Guidelines to  Good Manufacturing Practice for Medicinal Products for Human and Vetinary Use
• The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.

We were inspcted by the MHRA for GCP in 2008 and for GMP in 2009.  We are also regularly audited by sponsors, typicaly participating in 12-15 audits per year.