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[av_rotator_item title=’Abteilung Für Zulassungen‘ link=“ linktarget=“ custom_title=“ av_uid=’av-4m6c93′]
[av_rotator_item title=’Abteilung Für Zulassungen‘ link=“ linktarget=“ custom_title=“ av_uid=’av-1wkjc7′]
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Das Geschäft der Pharmaindustrie ist stark durchreguliert. Die Abwicklung von Zulassungsanträgen ist eine der Hauptaufgaben unserer Abteilung für Zulassungen (oder Regulatory Affairs), da dieser Schritt für den Marktzugang medizinischer Produkte unerlässlich ist.
Ohne vorherige Zulassung durch die zuständige Gesundheitsbehörde darf kein Medikament vermarktet werden. Abhängig vom Produkttyp (Arzneimittel, Medizinprodukte, Kosmetika, Nahrungsergänzungsmittel usw.) sind die Anforderungen für die Marktzulassung unterschiedlich.
Die Europäische Arzneimittel-Agentur (EMA) verlangt beispielsweise, dass die Zusammenfassungen der Datenblätter, der Packungsbeilagen sowie der Etiketten in den Sprachen aller Mitgliedstaaten, in denen das Produkt vermarktet wird, zur Verfügung gestellt werden. Der Erhalt der Zulassung in anderen Ländern der Welt kann es auch erforderlich machen, dass sprachliche Voraussetzungen erfüllt werden müssen, die die zuständigen Behörden vorschreiben.
Aufgrund des technischen, vertraulichen und rechtlichen Charakters der unterschiedlichen zu übersetzenden Dokumente und Texte werden unsere Übersetzer, Lektoren und Korrektoren nicht nur in der Fachterminologie, sondern auch im Hinblick auf die Verfahren geschult, die in den zu übersetzenden Texten beschrieben werden, sodass die fertiggestellte Übersetzung klar, präzise und originalgetreu ist.
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[av_heading heading=’ZULASSUNGSUNTERLAGEN‘ tag=’h4′ link_apply=“ link=’manually,http://‘ link_target=“ style=’blockquote modern-quote modern-centered‘ size=“ subheading_active=“ subheading_size=’15‘ margin=“ padding=’10‘ color=“ custom_font=’#ae8ca3′ custom_class=“ id=“ admin_preview_bg=“ av-desktop-hide=“ av-medium-hide=“ av-small-hide=“ av-mini-hide=“ av-medium-font-size-title=“ av-small-font-size-title=“ av-mini-font-size-title=“ av-medium-font-size=“ av-small-font-size=“ av-mini-font-size=“ av_uid=’av-2lavt3′][/av_heading]
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• Qualitätsberichte
• Berichte zur therapeutischen Positionierung (IPT)
• Genormte Arbeitsverfahren
• Anpassung der Zusammenfassungen klinischer Studien für Laien
• Usability-Tests
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• Satzweise Untersuchung von Proben
• Protokolle zur Validierung der Herstellung
• Etikettierung
• Gebrauchsanweisungen
• Packungsbeilagen
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• Technische Datenblätter
• Bewertung der Bioverträglichkeit
• Prozessvalidierung
• Klinische und präklinische Gutachten
• Prozessprotokolle und Protokolle klinischer Studien
• Zulassungsdossiers
• Risikobewertung
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[av_heading heading=’BENÖTIGEN SIE EINEN KOSTENVORANSCHLAG?‘ tag=’h5′ link_apply=“ link=’manually,http://‘ link_target=“ style=’blockquote modern-quote modern-centered‘ size=“ subheading_active=“ subheading_size=’15‘ margin=“ padding=’10‘ color=’custom-color-heading‘ custom_font=’#000000′ custom_class=“ admin_preview_bg=“ av-desktop-hide=“ av-medium-hide=“ av-small-hide=“ av-mini-hide=“ av-medium-font-size-title=“ av-small-font-size-title=“ av-mini-font-size-title=“ av-medium-font-size=“ av-small-font-size=“ av-mini-font-size=“ av_uid=’av-2un6af‘][/av_heading]
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