Medical Writing Services and Consultancy

The team of medical writers comprises primarily MD/ PhD-level scientists who write and develop a wide range of documents for registration or regulatory purposes according to clients’ specifications. The quality and the accuracy is based on a wide range of collaboration with clinical research professionals, including academic professionals, KOLs, medical doctors and clinical pharmacologists. These medical writing services included:

  • Medical expert state,emt
  • Study Report (CSR)
  • Investigator's Brochures (IB)
  • Clinical Expert Reports on CTD modules (Clinical and Nonclinical Overview/Summary)
  • Development/consultancy on SPC/PL
  • User Testing Projects and Readability Reports (UT)
  • Pediatric Investigational Plan (PIP/Waiver)
  • Risk Management Plan (RMP)

Within the recent years the MEDIX regional team managed over hundred and fifty regional consultancy projects included successful application to support clinical development, bioequivavlence, product registration in Hungary or within the European Union.