Consolidating decades of professional experience with actual requirements

MEDICAL WRITING
  • Clinical Trial Protocol (CTP)
  • Clinical Study Report (CSR)
  • Patient Information/Informed Consent (PI/IC)
  • NIS Observation- and Evaluation Plan
  • NIS Final Report
  • Clinical and non-clinical parts of the common technical document (CTD)
  • Clinical/Non-clinical Expert Statements
  • Summary of product Characteristics (SPC)
  • Patient Information Leaflet (PIL)
  • Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report (PSUR/PBRER)
  • Development Safety Update Report (DSUR)
  • Risk Management Plan (RMP)

 

 

 

 

 

 

 

 

 

 

 

 

Downloads

Quality Management Brochure
(pdf, 1.1 MB)

Company Presentation
(pdf, 604 KB)

Competence

ISO Certificate

TÜV Austria

Certificate
Austrian Federal Economic Chamber