Medical Writing

Our medical writers help you to structure scientific preclinical or clinical 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 team members are highly skilled with previous experience from pharmaceutical development, clinical trials, and academia.

Services include for example:

  • Clinical study or investigational reports
  • Clinical and investigational protocols
  • Clinical evaluation reports for Medtech products
  • Investigator’s Brochure (IB)
  • Conformity and benefit-risk assessments
  • Aggregate periodic safety reporting (PSUR/PBRER, DSUR)
  • Preclinical reporting
  • Dose-rationales
  • Peer-reviewed literature summaries
  • Clinical & nonclinical overviews and summaries (CTD module 2)
  • Environmental information at fass.se

Contact Maria Santesson for further information.