Apotex

Expertise in Simulation Testing and Thermal Packaging Qualification Prepares Biosimilar for FDA Review Meeting

Challenge

Apotex turned to Modality Solutions to design, document, and review their proposed approach for simulation testing and thermal packaging qualification in preparation for their FDA review meeting.

Objectives

  1. Identify correct simulation studies to demonstrate DP quality during transit
  2. Reviewing and comparing EU shipping studies with US distribution 
  3. Proposing and authoring a simulation study protocol
  4. Preparing management team to discuss the approach & gain approval

Results

After presentation to the FDA, see how Modality Solutions’ recommendations and consultation helped the product move forward in the approval process.

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