Marketing Authorisation Holder and Legal Representation Services

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.

Marketing Authorisation Holder

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

medical team having a meeting with doctors in white lab coats and surgical scrubs seated at a table discussing a patients records,success medical health care, Medicine doctor

KOL Interactions

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

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