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SERVICES

Approval and maintenance of medicinal products in Austria/the EU

Do you want to approve medicines in Austria and are unsure which is the best submission pathway? Or do you need help maintaining existing licenses? Then I can help you.

In der Apotheke

Taking on legally required functions as well as interim manager

I can provide the following functions:

  • general manager according to trade law

  • information officer

  • ​local person for pharmacovigilance (LPPV)

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Group Discussion

Release of advertising materials and Labeling

I can check the accuracy of your advertising materials and labeling and also approve them in my role as information officer.

Auswahl an Pillen

Project management / process optimization / SOP creation

  • Project management: Planning, controlling and implementing projects — on time, transparently and goal-oriented.

  • Process optimization: Analysis of existing processes, identification of improvement potential and implementation of customized solutions.

  • SOP creation: Development of clear, practical Standard Operating Procedures (SOPs)

Stapel von Dossiers

Drug lifecycle

Not enough manpower in the approval department, too many projects at the same time? Lacking the necessary expertise? I take care of changes in the dossier for you, from smaller variations to complex changes such as manufacturing transfers or OTC switches or the complete support of the product as well as communication with the authorities.

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