▪ A global pharmaceutical company needed to author CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product
▪ This work included authoring 9 CSRs (8 Phase 3 and 1 Phase 2b) as well as the Integrated Summaries of Efficacy and Safety (ISE and ISS), Summaries of Clinical Efficacy and Safety (Modules 2.7.3 and 2.7.4), Summaries of Biopharmaceutic Studies and Clinical Pharmacology (Modules 2.7.1 and 2.7.2), and the Clinical Overview (Module 2.5)
▪ All documents produced were of the highest quality and in submission-ready format, and both marketing applications were submitted to the US and EU regulatory agencies according to the client’s timelines. The combination product was approved in both the US and the EU