248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2

Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction. Ron Najafi knows what rigorous analytical work actually looks like under pressure. As founder and CEO of Emery Pharma, he led the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA formally validated and that reshaped how the industry approaches nitrosamine risk assessment. In Part 2, ...