Introduction of medicinal products for human use on EU markets
Submission of dossiers to the local Agency and monitoring the registration process the marketing authorization is obtained
Reporting medical incidents within the pharmaceutical system (establishment, implementation and monitoring of pharmacovigilance systems)
Maintaining products on individual markets (documentation renewal)
Product- and licensing-related activities (working with co-marketing or co-promotion partners, contract negotiations, license-off, license-on)
Transferring technology related to medicinal products for human use
Consulting (feasibility and price studies, market analysis, health system, review and interpretation of European Directives, interpretation of European Guidance Documents and legislation)
Introduction of medicinal products for human use on EU markets
Submission of dossiers to the local Agency and monitoring the registration process the marketing authorization is obtained
Reporting medical incidents within the pharmaceutical system (establishment, implementation and monitoring of pharmacovigilance systems)
Maintaining products on individual markets (documentation renewal)
Product- and licensing-related activities (working with co-marketing or co-promotion partners, contract negotiations, license-off, license-on)
Transferring technology related to medicinal products for human use
Consulting (feasibility and price studies, market analysis, health system, review and interpretation of European Directives, interpretation of European Guidance Documents and legislation)
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