European Regulatory Affairs Limited
We take the pain out of Regulatory Affairs so that you can take your medicine to the next level.
We each have vast years of experience in this industry. We all have a passion for ‘the details’, for problem solving and finding a solution that works best for you. This enables our incredible team to go above and beyond to support your applications and projects in any way we can.
We value and support one another so we can do our best work together. We are all very upfront and direct here at ERA. We trust one another and treat each other with respect, this is part of our company culture and keeps us connected. Our ultimate goal is to help our clients sell the safest and most beneficial medicines while maintaining awareness of their resources. We are here to guide you through the regulatory labyrinths and we look forward to taking this journey with you.
We specialise in EU and UK medicinal product applications of every kind. We support large and small companies all over the world to obtain and maintain their marketing authorisations. We are the only Irish member of a pan-European network of consultants called EuDRAcon and can therefore provide local support and services across the EU, EEA and UK.
We utilize an extensive network of dedicated experts to provide you with Biowaiver justifications, Clinical and Non-Clinical Overviews, Environmental Risk Assessment reports, Medical Device support, Toxicology reports, User Testing and more….