We take the pain out of Regulatory so that you can take your Medicine to the next level.
Our ultimate goal is to help our clients sell the safest and most beneficial medicines while maintaining awareness 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….