If you are aiming to develop or market a healthcare product in Europe, but don’t have a physical presence here, then partner with us. Our Bridge to Europe™ is an alternative to partnering with a large CRO, large pharma or going it alone. We can look after everything for you.
If you wish to apply for and hold a Marketing Authorisation in Europe, then you need to establish a legal entity within the EEA to hold that MA. We can establish a legal entity for you in the EU via our Irish office. We can then oversee all the duties required of an MAH on your behalf.
In addition to our other services, you we can provide solutions for your Medical Affairs, QP & Distribution oversight and Reimbursement body interaction responsibilities
You will need a legal representative in the EEA and non-EEA countries in order to conduct clinical research. We can take on that role. This will require our involvement in audits and vendor selection as well as oversight of processes such as IMP supply. We also would be involved in regulatory inspection preparation, hosting and responses.
Oversight of clinical research is not just a requirement of the Legal Representative, as ICH GCP and European Legislation make it clear that the Sponsor retains overall responsibility. We will work with you to ensure that you can demonstrate oversight of all the European processes for which you are responsible as Sponsor.
You will want to develop a relationship with KOLs in Europe during the development phase and ahead of marketing authorisation. Having KOL advocates helps shape European strategy, regulatory interactions, study recruitment and, ultimately sales. We are experts at running expert panels in a manner that gets the answers you need and develops strong relationships with the decision makers that matter.
These videos summarise some key challenges you may face in developing or marketing a medicinal product in Europe. We can help answer all those challenges.
Developing a medicine in Europe
Marketing a medicine in Europe
