European Regulatory Affairs Ltd

European Regulatory Affairs Limited (ERA) is a specialist consultancy that removes the complexity from regulatory affairs, enabling pharmaceutical and medical‑device companies to bring their medicines and products to market with confidence. Based in the Dungarvan Enterprise Centre, Co. Waterford, the firm draws on a wealth of industry experience and a passion for detail‑driven problem solving to guide clients through the EU and UK regulatory labyrinths.

ERA’s core services span the full spectrum of medicinal‑product applications, including preparation of biowaiver justifications, clinical and toxicology reports, user‑testing documentation and medical‑device support. The team also offers training and compliance advice, helping both large multinational firms and small innovators secure and maintain marketing authorisations across the EU, EEA and United Kingdom. As the sole Irish member of the pan‑European EuDRAcon network, ERA can provide seamless, localised support throughout Europe while leveraging a broad network of dedicated experts.

With a culture built on openness, mutual respect and a commitment to delivering the safest, most beneficial medicines, ERA partners with clients to navigate regulatory challenges efficiently and effectively.