It’s business as usual –
PDS welcomes EU expansion
Changes are ahead (post-Brexit) for pharma companies with licences in the EU and the UK. EMA and the HMA have recently issued a set of guidance notes to help MAH’s understand the steps they need to take in readiness for when the UK leaves the European Union at the end of March 2019.
Whilst it is largely still unclear what the future relationship between the EU and UK will look like in terms of the regulatory framework, MAHs need to prepare now.
In terms of pharmacovigilance, it will be necessary for UK MAHs to have a QPPV and PSMF located within the EU/EEA. In order to support our clients, PDS will be opening an office located within the EU/EEA so as to continue providing both QPPV services, whilst also being able to house PSMFs in all European countries.
We will be working closely with our existing clients to ensure this transition is seamless and their regulatory responsibilities continue to be met. We also welcome enquiries from new clients who are seeking guidance and support with these business critical requirements.
To find out more Contact Us today.