Your European Partner for Oral Explanations
& CRITICAL ASSESSMENTS
WHO WE ARE
EMA Solutions provides a unique platform of EU Regulatory and Scientific Experts with the aim of preparing and helping Applicants for interactions with the EMA Committees. The team of experts at EMA Solutions is comprised of ex-CHMP, National Competent Authority and FDA Assessors, as well as seasoned industry experts. We have years of direct experience of OEs, seen from both inside the EMA and from the industry perspective. Our experience allows us to give you a unique insight into the workings of CHMP and the best possible preparation for an OE. In particular, for a critical CHMP OE at Day 180 during the MAA, it is essential to have the right scientific/medical expertise and regulatory support, to have a clear and concise communication strategy, and to be prepared for the meeting room dynamics at EMA facilities. Our experts are selected on a project-by-project basis responding to client needs.
Similarly, for interactions with COMP, PRAC and PDCO, our team’s experience is second to none, having worked successfully on a range of OEs.
At EMA Solutions we believe that it is not only important to have the right technical content, but also to convey your message effectively. Therefore, our service includes dissemination strategy and support so that you can reap the full rewards from generating the technical content for an OE, through clear and effective communication. This integrated approach is designed to give our clients the best chance of success at these critical timepoints.
EMA Solutions’ expert team also conducts Independent Scientific Advice assessments for clients when time, resources or other issues make approaching EMA or national agencies difficult
OUR UNIQUE OFFERING
EMA Solutions provides an extensive, profound, added value experience in managing OEs and other crucial but challenging aspects of regulatory applications.
We have an impressive network of experts, including former regulators and senior level industry executives, who together can provide a unique insight into EMA / CHMP expectations.
Our combined experience of working on “both sides” of MAA submissions – industry and agency – means that we can help clients tailor their written and oral communication with EMA in an optimum fashion in order to reduce risk and ensure the greatest chance of success.
EMA Solutions guarantees the greatest level of professionalism together with the highest scientific and regulatory standards. The two aspects are recognised as key factors to successfully navigate OEs at the EMA.