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Medical Writing Services

Accelerate product development with medical writing services that efficiently and accurately tell your drug-development story

Regulatory dossier authoring services

Our services can be used from the earliest stages of development to approval and post-approval, ensuring the success of your product throughout the entire lifecycle.

  • Investigational New Drug (IND) applications
  • Clinical study reports (CSRs)
  • Patient narratives
  • Study protocols and amendments
  • Pediatric study plans (PSPs)
  • Risk management plans (RMPs)
  • Manuscripts
  • Investigator’s brochures
  • Safety reports (Development Safety Update Report [DSUR] and IND annual reports)
  • Meeting information packages for regulatory agency meetings

  • New Drug Applications (NDAs)
  • Biologics Licensing Applications (BLAs)
  • Marketing Authorization Applications (MAAs)
  • Common Technical Documents (CTDs)
  • Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE) sections
  • Safety reports (120-day safety updates and Periodic Safety Update Reports [PSURs])
  • Responses to questions (RTQs) from regulatory agencies 

Unsurpassed experience

Strategy and success

Case Study: A Strategic Partnership Leads to Successful Outcomes

Medical Writing Services

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