European Regulatory Affairs Ltd

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Business & HR ConsultancyIndustrial Services

About Us

ERA helps EU and non-EU pharmaceutical and biotech companies successfully access and maintain products in the European market through expert regulatory strategy, submission management, MAH services and lifecycle support.

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 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.