Explore how Agos Pharma can provide the framework required to conduct clinical research and hold marketing authorisations in the EU and UK. Learn more about our approach today.
MAH Services & Legal Representation
Are you a pharmaceutical company or biotech seeking to enter the European market?
Learn about our Bridge to Europe™ solution, a tailored service that simplifies the regulatory process and ensures you have the support needed to expand into the EEA.
Marketing Authorisation Holder and Legal Representation Services
Expanding into Europe or the UK with your healthcare product?
With Agos Pharma as your partner, we can act as your Legal Representative in the region, providing the local contact representing you as Sponsor. This fits perfectly with our Clinical Operations oversight capabilities.
As you approach registration for your product in the region, we can not only support your regulatory and pharmacovigilance preparations, but also help you establish a legal entity to hold your Marketing Authorisation.
Bridge to Europe™
Agos Pharma offers a streamlined, cost-effective alternative to entering the European market. Our Bridge to Europe™ service ensures that your product is fully supported in regulatory matters, from marketing authorisation applications to ongoing post-market obligations, without the need for a physical presence in Europe.
Explore our suite of services designed to support your European expansion. From Marketing Authorisation Holder services to Legal Representation & Oversight, we provide comprehensive solutions to ensure your product is fully compliant with European regulations.
Marketing Authorisation Holder (MAH) Services
Explore our suite of services designed to support your European expansion. From Marketing Authorisation Holder services to Legal Representation & Oversight, we provide comprehensive solutions to ensure your product is fully compliant with European regulations.
Marketing Authorisation Holder (MAH) Services:
If you are looking to obtain a Marketing Authorisation in Europe, you must appoint a legal entity within the EEA to hold that authorisation. Agos Pharma offers an efficient and seamless solution by establishing an MAH for you through our office in Ireland. We oversee all required MAH duties, including interactions with medical affairs, Quality Manager (QP) and distribution oversight, as well as managing your relationship with reimbursement bodies.
With Agos Pharma supporting your MAH, you can confidently navigate the regulatory landscape and ensure all responsibilities are met.
Legal Representation & Oversight:
To conduct clinical research in the EEA, you need a legal representative. We take on this essential role for you, ensuring that you meet the regulatory requirements and remain in full compliance throughout the development process. Our legal representation includes vendor selection, IMP supply oversight, audit management, and preparation for regulatory inspections. We also offer hosting and responses for any inspection enquiries, ensuring that you meet the full scope of sponsor responsibilities, as outlined by ICH GCP and European Legislation.
Agos Pharma’s legal and regulatory expertise ensures you are compliant with all necessary oversight during clinical trials, even if you do not have an on-the-ground presence in Europe.
