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Medical Writing

Strategic Document Planning

  • Design and write documents that will meet the highest scientific, regulatory, and industry scrutiny
  • Consult with you to determine your key messages and to ensure that these are conveyed accurately, consistently, and clearly across all of the documents in your clinical development and registration programs
  • Attention to detail with regard to scientific content, regulatory guidelines, specialized medical vocabulary, consistency in terminology and key concepts, and correct grammar and syntax

 

Medical Writing Services

  • Presentations
  • Manuscripts
  • Advisory Committee Brochures
  • Responses to Regulatory Agencies
  • Briefing Documents for Regulatory Agencies
  • Safety Update Reports
  • EU Marketing Authorization Applications (MAAs)
  • US New Drug Applications (NDAs)
  • Investigational New Drug (IND) Applications
  • Investigator Brochures
  • Patient Narrative Summaries
  • Clinical Study Reports

 

  • Process Management

    • Crises associated with changing timelines and priorities
    • Timelines
    • Author relationships