QSCL’s Experience
• NCEs, route switches, line extensions and generic products
• strategic and operational management of development and regulatory activity,
including several large product portfolios
• meetings with EMA, and EU and USA national agencies for phase I to III
• regulatory support of approximately 20 preparations for launch
• a wide variety of MA variations and ownership changes
• regulatory due-diligence:
o dossier defence and review for out- and in-licensing respectively
• in-house staff training