A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic and European operations, but new markets such as Mexico and Brazil showed to have certain challenges that required support from Lean Biologix. A high level summary of challenges is shown below:

  • High import taxes for shipping systems that impacted the financial distribution model
  • Long lead times and customs variability for importing shipping systems
  • Vendor onboarding, procedure development and training requirements posed risk to launch timeline

Lean Biologix Process:

  • Collaborated with client and in-country distributor to identify shipping options
  • Collected and reviewed available validation data for shipping options
  • Assessed test data against client requirements and industry/regulatory requirements
  • Documented technical risk assessment to approve country-specific shipping options for use in lieu of performing additional qualification testing
  • Defined and executed strategy for real time shipping studies to document live use cases in accordance with regulatory agency requests

Summary of Engagement

Short Term Wins:

  • Approved shipping options and met launch timelines
  • Identified areas of improvement for 3PL/Affiliate process

Long Term Wins:

  • Lean Biologix worked with internal and external stakeholders to implement a sustainable process for long term growth
    • Strategy documents
    • Processes and procedures
    • Developed RFP/RFI Checklist
    • Established minimum requirements for shipping solutions to expedite review process
    • Closed gap for supporting 3PL/Affiliates when client preferred shipping systems are not available or feasible to implement in-country
    • Supporting retrospective review of existing 3PL/shipping systems by market area