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Regulatory Affairs

In the field of regulatory affairs, we offer you a comprehensive range of services that covers the entire lifecycle of your products:

  • New submission of marketing authorization application (NAS, KAS)

  • Maintenance of marketing authorization (variations, renewal)

  • Preparation of documentation modules 1–5 of the registration dossier

  • Adaption of the EU dossier to specific requirements in Switzerland (Swissmedic)
  • Evaluation of marketing authorization documents
  • Advice on the development of marketing authorization strategies
  • Creation of eCTD sequences (software eCTDmanager) and electronic dossiers in eDok format
  • Control and maintenance of medicinal product information and packaging materials
  • Taking over the function of marketing authorization holder for companies not having a pharmaceutical operating license in Switzerland
  • Training of new employees in the field of regulatory affairs

MARAS AG
Alte Steinhauserstrasse 21
CH-6330 Cham

Phone & Mail
+41 41 747 31 31
contact@maras.ch

Impressum
Datenschutz
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