247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1

When drug safety fails, patients and entire markets pay the price. Understanding your CMC isn't just compliance — it's the line between therapeutic promise and product recall. Ron Najafi has lived that reality firsthand. As founder of NovaBay Pharmaceuticals and Emery Pharma, he spent decades building companies at the intersection of analytical chemistry and drug development. His investigation into nitrosamine contamination in ranitidine — which led the FDA to formally validate Emery Pharma's...