Case Study on Market Access in Europe

This case study outlines the process undertaken by a US-based client seeking market access to the European Union and Switzerland. The client faced challenges navigating the regulatory landscape across multiple countries and organizations. ProPharma Group collaborated closely with the client to develop a Quality Management System (QMS) compliant with EU regulations and to acquire necessary licenses, including the Manufacturing & Importation Authorization (MIA) and Warehouse & Distribution Authorization (WDA). The proactive approach and thorough preparations led to a successful inspection by local authorities, resulting in MIA license approval within 24 hours. The case study details the gap assessment and license application plans developed by ProPharma, including revisions to existing Standard Operating Procedures (SOPs) to ensure compliance. The client benefited from expedited market access, increased productivity, and positive feedback due to the effective partnership with ProPharma, which continues to support additional licensing needs in Europe and Switzerland.