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Questions to ask before a CDMO transition:

🔍 REGULATORY IMPACT 


✓ What are the proposed changes and their regulatory impact? 


Recommend: Keep changes to a minimum and brainstorm how to reduce changes. Don't simply follow the SOP of a CDMO. 


💰 FINANCIAL CONSIDERATIONS 


✓ How do you ensure this transition won't negatively impact COGS? 


Recommend: Share costed BOM, work instructions, and labor cycle time as assumptions in the RFQ package. 


🔄 OPERATIONAL CONTINUITY 


✓ Should the new CDMO adopt your current suppliers or establish new relationships?


Recommend: No supplier/raw material change during the transition period. Plan a long-term strategy to change and estimate associated costs. 



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