About Our Team
Our incredible team at European Regulatory Affairs Limited are dedicated, professional and have extensive experience in all areas of EU and UK Regulatory Affairs. Our individual team members bring diverse expertise together to find solutions to our clients’ unique challenges. Before joining ERA we have all either worked in pharmaceutical companies or within the Irish competent authority.
Our combined experience spans all aspects of the pharmaceutical industry and covers all dosage forms including tablets capsules, solutions, suspensions, as well as creams, parenterals and other sterile products with a strong emphasis on regulatory strategy and guidance.
Our team has vast experience managing complicated projects in multiple Member States and has therefore established very strong working relationships with the regulators throughout Europe and the UK.
We can provide expert advice in all areas of product development, regulatory strategy, dossier preparation and MA submission through to national phase registration, variations, renewal and more…
When needed we utilize an extensive network of dedicated experts to provide specialist support such as Biowaiver justifications, Clinical and Non-Clinical Overviews, Environmental Risk Assessment reports, Medical Device support, Toxicology reports, User Testing and more…. European Regulatory Affairs Limited has an extensive range of training options available which can be tailored to your company’s needs.