Compliance and Regulatory Issues
- Our warehouse is temperature controlled with cold room storage facilities
- We are UK Government approved, holding a Wholesale Dealer’s Licence from the Medicines and Healthcare products Regulatory Agency (MHRA) and a Home Office Licence for the supply of Controlled Drugs
- Our facilities are open to audit by clients, as well as being regularly inspected by the UK licensing authority
- We are fully compliant with the EU Clinical Trial Directive and UK and international standards for Good Distribution Practice (GDP)
- We regularly carry out internal audits of our performance (click here for our performance statistics)
- We have been awarded Investors in People (IIP) status and have ISO 9001 accreditation
European Union
Significant changes in European law governing clinical trials came into effect on 1st May 2004. The main aim of the Directive - The Medicines for Human Use (clinical trials) Regulations 2004 - is to simplify the administrative processes governing clinical trials and therefore establish a harmonised procedure for clinical trials throughout the European Community.
To find out more about what this new Directive means in the UK, please click here.
ADAllen Pharma is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) to wholesale pharmaceuticals.
United States of America
Clinical trials in the USA are regulated by the Center for Drug Evaluation and Research within the Food and Drug Administration (FDA).
Click here to find out more about the regulations governing trials in the USA.
