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 infrastructure in place to ensure a seamless transition from pre-Brexit to post-Brexit. We can reduce the risk and remove the pain by managing the entire process for you.
- We have an EEA based system and EU QPPV based outside the UK in the EEA.
- We can act as your MAH in the EEA.
- 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 updates & xEVMPD.
- 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.
Many concerned companies have already contacted us to help them ahead of these impending changes, including other Regulatory Affairs and Pharmacovigilance service providers based in the UK.
We are considered by many as being a go-to organization to handle this impending issue.