EU Supports

We provide a wide range of solutions and services with EU focus to help make your medicines and devices available to patients in the EU.

Merilane's bespoke ‘Access EU’ programme is designed to support clients based outside the European Union through every stage of the product lifecycle — from early-phase clinical trials to successful market entry and post-authorisation obligations.


We provide end-to-end regulatory and operational support including EU Legal Representation, Clinical Trial Authorisation (CTA) submissions, management of Investigational Medicinal Products (IMPs), Marketing Authorisation (MA) applications, and acting as EU Marketing Authorisation Holder (MAH) where required. Post-approval, we offer robust pharmacovigilance oversight, variations and renewals management, regulatory intelligence, and continued compliance with EU GxP and safety reporting requirements.


Whether you are launching your first trial in Europe or seeking to commercialise a new medicinal product, our Access EU programme ensures seamless navigation of complex EU regulatory frameworks.