Regulatory Affairs Services

In the field of marketing authorization for medicines, we offer you a comprehensive range of services, starting with advice regarding suitable marketing authorization strategies, through the preparation and submission of your documents to the support of your products after approval:

  • New submission of marketing authorization application (NAS, BWS)
  • Maintenance of marketing authorization (for example change request, renewal)
  • Preparation of documentation modules 1-5 of the registration dossier
  • Adaptation of EU dossier to specific requirements in Switzerland (Swissmedic)
  • Creation of eCTD sequences (software: eCTDmanager) and electronic dossiers in eDok format
  • Submission of PSUR / PBRER
  • Development/creation of GSASA sheets for hospital preparations
  • Bibliographic search
  • Evaluation of marketing authorization documents
  • Advice on the development of marketing authorization strategies, scientific advice
  • Clarification during negotiations and meetings with authorities
  • Support for medical devices (classification/demarcation, technical documentation for conformity assessment bodies, advertising)
  • Training of new employees in the field of marketing authorization