MAA (Marketing Authorization Application) submissions to EMA follow a prescribed process of collaborative evaluation. While the high-stakes meeting types are described elsewhere (Scientific Advisory Groups and Oral Explanations), intellectual rigor and exquisite communication strategy must permeate the volumes of written comments that precede these meetings.
ECG’s Message Matrix℠ process is designed to capture and align both written and spoken communication around messages, issues, and responses. Applying this discipline early and consistently means that downstream there is less confusion blocking the path to an approval recommendation. It also means that your application will have the appropriate medical context from the filing forward.
As regulatory communications experts, ECG’s Principals will facilitate the building and evaluation of your submission communication, as well as explore with you all the argumentation options that should be considered. We don’t replace your scientists and medical experts – we help their communication say exactly what needs to be said in a manner that is well-tuned to the regulatory review audience.
Please contact us via email or at +1-201-894-8200 to discuss the custom communication strategy we can create for your upcoming MAA submission.