Medical Writing

Medelis provides comprehensive medical writing services for all points from pre-IND through NDA.

Our writers’ skills and experience in oncology ensures that we’re complying with all regulatory guidelines and accurately presenting study results, and providing clear, concise, accurate and polished documents.

We can also provide study-specific services for:

  • Protocols
  • INDs and investigator brochures
  • Clinical study reports
  • Regulatory briefing documents
  • Clinical safety & efficacy summaries
  • Abstracts for professional meetings
  • Presentations for FDA and other regulatory meetings
  • Manuscripts