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) /Periodic Benefit-Risk Evaluation Report (PBRER)
MEDICAL DEVICE
  • Clinical evaluation report (CER)
  • Post market clinical follow-up (PMCF)
  • Risk management report
  • Biocompatibility report
  • Periodic safety update reports (PSUR)
OTHER
  • Manuscripts
  • Literature searches and summaries

Please contact Elisabeth Widmark for more information