Developing a compliant UK Local Affiliate function

Jackie Roberts gives her thoughts on setting up a local affiliate in the UK

“It can be quite a trial having to set up a local affiliate function in the UK especially for companies who are new to the market with only a few (or even only one) product. The requirements for compliance, of course, are always present regardless of how many products you have but it can be a complicated process ensuring that all the pharmacovigilance, regulatory and quality requirements are satisfactorily met. I have previously worked with companies who outsource this, but they  often split the roles and responsibility between different vendors resulting in issues as activities can be dropped or lost between the vendors and the company leading to audit findings and non-compliance.

I wondered how to make this better and easier for companies to enter the UK market with minimal fuss and maximum value, and together with my business partner, Lisa, have developed PharmaGuard’s one stop shop for local affiliate activities. In our model you will have one contact at PharmaGuard and we, together with our trusted consultants, will create you a bespoke local affiliate function that ensures you operate compliantly, with minimum fuss and with maximum value.”

If you are interested in discussing this further then please contact us either via the website contact form or via email at info@pharmaguard.co.uk Your compliance is our business, and we want to support you in achieving excellence.