Consolidating decades of professional experience with actual requirements

REGULATORY AFFAIRS SERVICES
  • Evaluation and dossier preparation
  • Pharmaceutical, pre-clinical and clinical reports, summary & overview 
  • according to CTD, e-CTD
  • National Marketing Authorization 
  • Maintenance and updates of Marketing Authorizations (LCM) - Renewals, variations, SmPC updates, PILs and Labelling
  • Consulting and Communication with Competent Authorities

 

 

 

 

 

 

 

Downloads

Quality Management Brochure
(pdf, 1.1 MB)

Company Presentation
(pdf, 604 KB)

Competence

ISO Certificate

TÜV Austria

Certificate
Austrian Federal Economic Chamber