Medical writing and bioethics

Regulatory dossiers

Writing support in extracting, compiling and reporting clinical data

Clinical trial applications

  • IND, clinical study protocols, investigator procedure

Marketing authorization submissions (EMEA, FDA, WHO)

  • Clinical summaries and clinical overview in CTD format
  • Clinical study reports
  • Clinical trial applications
  • Responses to questions from authorities
  • Presentations for meetings with regulatory authorities