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 collaboration with clinical research professionals, including academic professionals, KOLs, medical doctors, and clinical pharmacologists, guarantee quality and accuracy. These medical writing services include:

  • Medical expert statement

  • 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)

In recent years, MEDIX regional team managed over fifty regional consultancy projects, including successful applications to support clinical development, bioequivalence, and product registration in Hungary or the European Union.

Join to our investigator portal!

If you are interested in participating in a clinical trial in the future as an investigator, please submit your contact details, along with the therapeutic area of your medical practice or coverage!