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- Translate your manufacturing and/or packaging needs into a comprehensive request for proposal/request for quotation
- Provide logistics planning and manage drug product manufacturing (all dosage forms)
- Perform pre-approval review of manufacturing and packaging batch documentation, technology transfer and validation documentation
- Create project plans through identification of tasks and durations required to complete preparation and distribution of clinical supplies
- Manage expiration dating, including relabeling (e.g. shelf-life extension)
- Formulate resupply strategy based upon supply preparation lead times, drug product shelf-life, enrollment rate, and time package is in use
- Monitor progress against GMP drug development milestones
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