Medical Writing

We can help you to report or summarise medical data into clear and readable texts in accordance with scientific principles and regulatory requirements.

We provide a wide variety of documents and reports throughout the life cycle of a pharmaceutical or medical device. Our skilled team members have previous experience from product development, clinical trials and academia.

Let us assist you with:

CLINICAL TRIALS

 

  • Investigator’s Brochure and IMPD
  • Periodic safety report (DSUR)
  • Study report
  • Study protocol
eCTD DOCUMENTS

  • Environmental risk assessment (ERA)
  • Risk management plan (RMP)
  • Quality overall summary
  • Nonclinical overview
  • Clinical overview
  • Nonclinical summary
  • Clinical summary
  • Periodic safety update reports (PSUR)
MEDICAL DEVICE

 

  • Clinical evaluation report (CER)
  • Post market clinical follow-up (PMCF)
  • Risk management report
  • Biocompability report
  • Periodic benefit-risk evaluation report (PBRER)
OTHER

 

  • Manuscripts
  • Literature summaries

Please contact Maria Santesson for more information