Your ANDA or Ours? A Smarter Approach to Pharma Product Transfers

The session will cover:

•The traditional transfer mindset vs. a smarter approach — why companies default to transferring their own formula and product, and why that's not always the best path

•When using a CDMO's existing ANDA makes more sense — time, cost, and regulatory advantages of leveraging an in-house ANDA rather than executing a full tech transfer

•The real challenges of tech transfer — common assumptions companies make (including around bioequivalence studies) and why the process is often more complex than anticipated

•Regulatory hurdles — when a CBE-30 is sufficient vs. when a Prior Approval Supplement or BE study is required, including delayed-release and controlled-release scenarios

•Who should be at the table — why outsourcing/procurement contacts alone aren't enough, and the value of engaging technical and regulatory stakeholders early