Επιχειρηματικό σχέδιο αναβάθμισης παραγωγικής εγκατάστασης βιομηχανίας φαρμάκου
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Keywords
Δεξμεδετομιδίνη ; Αναβάθμιση παραγωγικής εγκατάστασης ; Φαρμακοβιομηχανία ; Annex 1 ; Επιχειρηματικό σχέδιο ; OEE ; Οικονομική ανάλυση ; Business plan ; Φάρμακο ; Φαρμακευτικός κλάδοςAbstract
The present thesis focuses on the development of a comprehensive business plan for upgrading a pharmaceutical manufacturing facility, with an emphasis on the production of the injectable formulation of dexmedetomidine. The study concentrates on compliance with the latest regulatory requirements of the European Union (EU GMP Annex 1), improvement of manufacturing efficiency, and enhancement of the company’s competitiveness within EU markets (European Commission, 2022).
The methodological approach combines market analysis using IQVIA data, assessment of the current state of the facility, identification of technical and regulatory requirements, design of the upgrade business plan, and financial analysis employing indicators such as NPV and IRR (Brealey et al., 2020). Furthermore, strategic tools such as SWOT, PESTEL, and Porter’s Five Forces are applied, along with key performance indicators (OEE, yield), to ensure a holistic evaluation of the project.
The analysis results demonstrate that the investment in upgrading the facility is technically feasible, regulatory-compliant, and economically viable. The adoption of advanced technologies (isolators, automation, digital systems) and full compliance with Annex 1 strengthen the company’s market position, ensuring quality, safety, and competitiveness (ISPE, 2022). The thesis concludes with specific recommendations for project implementation, sustainability enhancement through ESG practices, and the company’s future growth.
Postgraduate Studies Programme
Πρόγραμμα Μεταπτυχιακών Σπουδών στη Διοίκηση Επιχειρήσεων για Στελέχη (Executive MBA)Department
Σχολή Οικονομικών, Επιχειρηματικών και Διεθνών Σπουδών. Τμήμα Οργάνωσης και Διοίκησης ΕπιχειρήσεωνNumber of pages
171Language
GreekCollections
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Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα