Your development plan is likely to have been long and complex. Our Medical Writing team is experienced in presenting your data in a clear and logical manner, to ensure your Key Messages are delivered consistently and coherently, the red thread throughout your documentation.

RApport can assist you with all aspects of medical writing including:

Full authoring to submission ready status, strategic outlines, or expert review with or without QC;

Development of documents for Module 2.5, 2.7 and 5 within the CTD, which can be optimised for EU, US or global submissions;

Clinical development documents (e.g. Investigator Brochures, protocols, interim and final study reports);

Clinical regulatory documents (e.g. responses to questions, white papers);