Medical Writing

FMD K&L has experienced medical writers that produce a wide-range of medical and scientific documentation in support of NDAs / sNDAs and EMAs (European Agency Filing). Our writers combine their extensive industry knowledge with their professional writing skills to produce documents that firmly meet the standards imposed by regulatory agencies. Whatever your medical writing needs, FMD K&L has the capabilities and the resources to support your goals and to ultimately help you launch innovative breakthroughs in the biopharmaceutical industry to benefit patients.  Our medical writing services include: 

  • Clinical Study Protocols
  • Investigator’s Brochures
  • Statistical Reports and Clinical Study Reports
  • Subject Narratives
  • IND Annual Safety Reports
  • Integrated Summaries of Safety / Efficacy
  • ICH E3 Compliant Templates for CSRs or Utilization of the Client’s Template 
  • Scientific Publications and Meeting Support
  • Manuscripts, Abstracts, or Slides for Posters or Presentations