Regulatory submissions at QSCL
• Regular scientific advice from EMA and main EU agencies
• CTA Applications including IMPDs and IBs
• More than 100 generic applications including at least 10 DCP Applications
and several line extensions
• Marketing Authorisation Application (MAA) CTD Modules 1-5 and follow-through
to grant of MA
• Orphan Drug and Ethics applications
• FDA preIND meetings, using established USA regulatory relationships as
required