Merrimack
New Drug Application (NDA) Support for a Temperature-Sensitive Drug
Challenge
Merrimack intended to file an NDA for MM-398, but they had not been qualified for a commercially-approved drug product. Additionally, there was uncertainty regarding the scalability or cost-effectiveness of the shippers used in the clinical supply chain.
Objectives
- Risk management plan to identify and mitigate risks
- Distribution validation master plan for MM-398
- Reduce total delivered cost of shipping
- Integrate pack out instructions into existing procedures
- Author sections of the NDA related to distribution
Results
See how Modality Solutions helped Merrimack complete its logistics network, including the selection and qualification of shipping containers and transport systems.
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