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Sunesis

Packaging and Label Testing for NDA Application Support

Challenge

When they entered Phase 3 clinical trials, Sunesis needed Modality Solutions to provide supporting data in protocols, summary reports, and study execution to validate the proposed methods of shipment, packaging, and label printing on the product cartons for their upcoming NDA submission.

Objectives

  1. Design and test three shipping configurations using our transport simulation lab
  2. Stability assessment of three printing options
  3. Review packaging-relevant sections of the NDA

Results

See how Modality used their vast experience in marketing authorizations (e.g., NDA) to support Sunsesis’ journey to approval for QINPREZO in 2015.

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