EMA SOLUTIONS

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... EMA Solutions selects the most appropriate team for our clients on a project-by-project..

Also known as: EMA

Primary location: Canary Wharf United Kingdom