Services Offered

  • Regulatory Writing
    • Protocols
    • Clinical study reports
    • Safety narratives
    • Investigator brochures
    • Briefing books
    • eCTD-compliant Module 2 documents (clinical and nonclinical)
    • Clinical evaluation reports
    • Regulatory responses
  • Scientific Communications & Publications
    • Strategic publication planning
    • Primary manuscripts for submission to peer-reviewed journals
    • Meta-analyses for submission to peer-reviewed journals
    • Congress abstracts
    • Congress posters
    • Slide decks
    • Clinical paper summaries
  • Strategic Project Management