The pharmaceutical industry is buzzing about Quality by Design (QbD). To date, most contract manufacturers have stayed out of the discussion, assuming that the phrase has little to do with their role. In reality, applying the principles underlying Quality by Design can differentiate contractors from competitors, strengthen the contractor/client relationship and make it possible to establish a business plan for products, processes and facilities. What’s more, the contractor can realize these benefits regardless of whether the client files a risk-based or a conventional New Drug Application (NDA).