Thanks to wide range backround of physicans and experts we are able to offer you processing of variously profilating analysis and expert reports (medical writings).

 

Expert reports, medical writings and preparation of CTD dossier:

  • Rx to OTC Switch Report
  • Addendum to Clinical Overview (ACO)
  • PSURs
  • Risk Management Plan
  • Enviromental Risk Assessment
  • CTD Modules 2, 4 and 5
  • Clinical Overview CTD modul 2.5
  • Clinical Summary CTD modul 2.7
  • Non-clinical Overview CTD modul 2.4
  • Non-clinical Summary CTD modul 2.6
  • Quality Overall Summary CTD 2.3
  • Risk-benefit evaluation - Report of clinical expert for purposes of registration renewal

 

Marketing materials:

  • Information review - comprehensive evaluation of available literary sources in structured form
  • Thematic analyses and literary comparative studies
  • Processing of information materials from available literary sources
  • Preparing of publications and marketing materials