European Regulatory Affairs Limited

European Regulatory Affairs Limited is a premier business consulting and services firm specializing in navigating the complex landscape of EU and UK medicinal product regulations. With a focus on streamlining regulatory processes, European Regulatory Affairs Limited empowers companies to advance their pharmaceutical products to the next level. The company supports both large and small organizations worldwide in securing and maintaining their marketing authorizations.

Located at Dungarvan Enterprise Centre, Fairlane Roundabout, Dungarvan, Co. Waterford X35 FC60, IE, European Regulatory Affairs Limited stands as the sole Irish member of EuDRAcon, a distinguished pan-European network of consultants. This affiliation enables the company to deliver localized support and comprehensive services throughout the EU, EEA, and UK. The company leverages an extensive network of dedicated experts to provide Biowaiver justifications, Clinical and Non-Clinical Overviews, Environmental Risk Assessment reports, Medical Device support, Toxicology reports, User Testing, and a range of other specialized services.

European Regulatory Affairs Limited is committed to providing knowledge-based solutions in regulatory affairs, project management, and compliance. As a leading consultancy, European Regulatory Affairs Limited ensures clients receive the highest level of expertise and support. We invite the management team of European Regulatory Affairs Limited to create a customized and exclusive company showcase and product listing on our platform to further enhance your market presence.