10.05.12
Q: You are going to outsource a new project, unlike any you had before. What homework will you do to try to assess what it should cost? Do you have any computer programs by which to price the project?
A: I assume that this question is geared towards outsourcing formulation development, analytical, and cGMP work. If so, then it is very important to know the prominent folks in the company and their background/expertise. It is also good to learn about FDA inspections and outcome. This provides an idea of how the existing quality system are. In addition, I would strongly recommend visiting the company to evaluate capabilities and meeting with technical folks for a brief discussion.
I am not aware of any software to assess the cost, since each project is different and each outsourcing company charges different amounts. I would suggest getting a non-binding estimate for the work from different vendors.
—Martin Steinman, Kuraray America
A: I assume that this question is geared towards outsourcing formulation development, analytical, and cGMP work. If so, then it is very important to know the prominent folks in the company and their background/expertise. It is also good to learn about FDA inspections and outcome. This provides an idea of how the existing quality system are. In addition, I would strongly recommend visiting the company to evaluate capabilities and meeting with technical folks for a brief discussion.
I am not aware of any software to assess the cost, since each project is different and each outsourcing company charges different amounts. I would suggest getting a non-binding estimate for the work from different vendors.
—Balaji Kadri, PharmaForm
