The process of establishing cultural compatibility may seem unnecessary, but it will prove invaluable during the manufacturing term. A site visit and an interview of key personnel are essential to probing the CMO and establishing a positive “comfort-factor” with them. The process will force you to ask questions and become comfortable with the group that will manufacture your product. Are these the people that will be “hands-on” during manufacturing? Where are their priorities regarding cost, schedule, and quality? Do they view you as an important customer or just someone in the queue?