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- Translate your clinical dosing regimen into drug supply requirements (quantity and strength)
- Package and label design
- Manage label approval process (develop English master label; collate country-specific translations; manage proof generation, review, and routing for final approval)
- IVRS specification development and review
- Develop a global distribution strategy and written plan, including cold chain methodology
- Forecast drug supply requirements for study initiation through last subject/last visit
- Monitor progress against clinical development milestones
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