In the past, when smaller U.S. biopharmaceutical companies wanted to enter the European market, they had two choices – go it alone, an approach that includes substantial cost, risk and uncertainty; or out-license the product to another company, which required them to give up control of the product and perhaps lessen the long-term value of their portfolio. Now they have a third option. By partnering with a well-established outsourcing specialist they can overcome much of the risk while taking advantage of a vast network of human resources and infrastructure across Europe. Through these partnerships, smaller biopharma companies can more efficiently get their drug into the market – without giving up strategic control or long-term value.  This paper outlines the challenges North American biopharma companies face when entering the European marketplace, the options they have for overcoming these risks, and how to choose the best approach.