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European Regulatory Affairs Limited

European Regulatory Affairs Limited is an Irish owned consultancy company providing expert Regulatory Affairs advice and support to the pharmaceutical industry. We work with companies all over the world to obtain EEA and UK Marketing Authorisations for a diverse range of products (Medicines and Medical devices). We are proud to work with large multinational companies as well as smaller start-up companies, helping them to achieve their goals.

We specialise in Regulatory strategy, Project management, Dossier services (Preparation, Submission, eCTD, etc.), Expert reports (Quality, Clinical, Non-Clinical, Environmental Risk Assessment, Biowaiver, Registration feasibility, Toxicology, User testing and more), Dossier audit and Gap analysis, CMC writing, Guidance on Reference Products, Training, Compliance and more ….

We are also part of a pan-European network of consultants, called EuDRAcon, of which we are the only Irish member. We can therefore provide local support and services across the EU, EEA and UK.

Contact us at info@ivowen.com or see our website www.ivowen.com