About

Navigating Europe’s regulatory landscape can be daunting without a local presence. We provide comprehensive regulatory services to support every aspect of your product development journey. From market authorisation submissions to ongoing compliance management, we help you stay aligned with the European Medicines Agency (EMA), national health authorities, and other regulatory bodies. Our team ensures that all the necessary regulatory documentation, including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), and Post-Marketing Surveillance (PMS), is submitted and managed efficiently. We also help you establish Pharmacovigilance and Risk Management Plans (RMPs) that meet EU standards.

To market your product in Europe, you are required to appoint a Marketing Authorisation Holder (MAH) within the European Economic Area (EEA). Through our Bridge to Europe™ service, we can establish your MAH, and provide you with the necessary legal and regulatory infrastructure to hold and manage the Marketing Authorisation for your product. We can handle all the duties associated with the MAH role, ensuring compliance with local laws and health authority requirements, which includes the Medicinal Product Information (SmPC), PILs (Patient Information Leaflets), and Labelling.

We provide comprehensive clinical development services across Europe, including study design, site selection, and patient recruitment. We can oversee your current CROs and our expertise in clinical trials ensures your studies meet all regulatory requirements and can be implemented efficiently, saving you time and money. We work closely with your team to provide on-the-ground support for clinical trials, including regulatory submissions, ethics approvals, and continuous monitoring of trial progress. Our team ensures real-time reporting and performance metrics so that you have complete visibility into your clinical development activities.

Pharmacovigilance is a crucial aspect of marketing any healthcare product in Europe. Through Bridge to Europe™, we offer end-to-end pharmacovigilance services, including safety data collection, adverse event reporting, and compliance with EU pharmacovigilance regulations. Whether you need a Qualified Person for Pharmacovigilance (QPPV) in the EU or require help with ongoing safety monitoring, we ensure that your product meets all European post-marketing safety requirements.

Managing vendors across multiple regions can be complex. Agos Pharma takes the burden off your shoulders by providing vendor management services. We coordinate with local suppliers, clinical research organisations (CROs), and other service providers across Europe to ensure that all activities are aligned with your project goals and timelines. We offer a single point of contact for your European operations, simplifying communication and ensuring consistent oversight throughout the process.