New Drug Application (NDA) Support for a Temperature-Sensitive Drug


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.


  1. Risk management plan to identify and mitigate risks
  2. Distribution validation master plan for MM-398
  3. Reduce total delivered cost of shipping
  4. Integrate pack out instructions into existing procedures
  5. Author sections of the NDA related to distribution


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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