Medical Writing | ПОБ, ПУР, МФСФ, Рег. досье, документы КИ


Our team prepares documentation on pharmacovigilance, registration and clinical trials in the format required by the legislation of the Eurasian Economic Union / European Union, as well as their mutual harmonization.

We are preparing the following documents:
  • Pharmacovigilance System Master File (PSMF)
  • Periodic Safety Reports (PSRs) regular and pursuant to Regulation No. 1583
  • Risk Management Plans (RMPs)
  • Standard operating procedures (SOPs), quality manuals and other quality management system (QMS) documents
  • Safety data exchange agreements with business partners
  • Resource package for safety communication to regulators / healthcare professionals / patients as part of the safety signal management process
  • Clinical study protocol and report
  • Clinical and non-clinical study overviews
  • Brochure Investigator
  • Report on the safety of the drug in development