Regulatory considerations have to be at the core of choosing a clinical trial supply partner. The importance of safety, pharmacovigilance and compliance with rigorous national and supra national bodies (e.g. FDA, EMA) cannot be over-estimated.
In Durbin you will have not only a partner that understands and complies with the regulations but one which puts quality at the centre of all it does.
Durbin - fully licensed
Durbin is licensed in its home country (UK) by the well respected MHRA as a wholesaler in Pharmaceuticals, Veterinary Products and Controlled Drugs – for more information please click here
Pharmacovigilance and recall
Durbin operates a complete recall scheme as approved by the UK MHRA. We will alert any sponsor to any recall or notification within two working days of being informed by the relevant innovator or wholesaler.
Compliance with client policies
Durbin will undertake a proactive approach to abide by and incorporate client policies into our working practices in all areas from supplier audits to equality policies. To discuss your requirements please contact us.
Durbin PLC is managed under a Quality Management System certified to ISO 9001:2008. All procedures are carried out as per robust Standard Operating Procedures (SOPs) which are regularly and frequently reviewed to ensure best practice. SOP’s cover all activities at our warehouse, offices and logistics operations. Details of our SOPs are available to clients.
Quality Managers and Responsible Persons
Durbin has a large Quality Management team encompassing three Responsible Persons and support staff. This team has extensive pharmaceutical experience and are mainly qualified Pharmacists. For more details of their experience please contact us.