Scientific & Medical Writing

We provide a wide variety of scientific and medical writing services, ranging from non clinical peer reviewed manuscripts to regulatory submissions and clinical documents.

Our services include:

  • Preclinical study reports
  • Clinical study reports (Phases I to IV) compliant with ICH E3 standards
  • Clinical protocols
  • Investigator brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Informed Consent Forms
  • PSURs
  • Narratives
  • Submission modules (CTD Sections 2.4, 2.5, 2.6, 2.7, 4 and 5)
  • PILs and readability questionnaires
  • EEC dossiers
  • Expert reports
  • Monographs
  • Scientific and protocol advice