Hi My Nitrosators!
I was told by a CMO that they are no longer going to create and/or revise existing nitrosamine risk assessments for their customers. They will just keep a copy of a nitrosamine risk assessment that the NDA holder creates on file. Is anyone else experiencing this? Typically we are used to received the assessments from our CMO’s since they are intimately involved with the manufacture and synthesis, and our company reviews and approves it after final edits are made. I’d love to know how other companies handle this.