Accelerating Speed-to-Market for OTC Products: Technical, Regulatory and Cost Considerations.

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