How we can help.
We offer a significant strategic advantage by providing an end-to-end service with Regulatory Affairs and Pharmacovigilance and have the legal and commercial infrastructures in place to ensure a seamless transition from pre-Brexit to post-Brexit, for both regions affected by Brexit (UK, EEA). We can reduce the risk and remove the pain by managing the entire process for you.
- We can establish a Pharmacovigilance system both for an EU MAH located in EU, and or a UK MAH with a PSMF located in the UK at a point where the reports of suspected adverse reactions are accessible electronically or physically.
- We can act as a MAH in the EEA and in the UK.
- We can handle your RMS switching and prepare, publish and submit all the variations and transfers of MAs for your products.
- We can handle all necessary PSMF & xEVMPD updates and adaptions to cover UK/EEA specific requirements .
- We can establish a legal entity in the EEA and the UK on your behalf.
It is unfortunately inevitable that if you are based in the UK, hold an MA in the UK, or have your EU QPPV in the UK, you will be affected by the UK’s decision to leave the European Union. We also believe that companies or MAHs will need to be adapted to work with this situation.
Arriello is considered a go-to organization to handle these impending changes for Pharma companies and other Regulatory Affairs and Pharmacovigilance service providers based in the UK.