Many small companies and universities can and do create GMOs. The process to create GMOs is well understood and straightforward. However, few have developed commercial GMOs. The challenge is that the expense and expertise necessary for global regulatory approval can be prohibitive (published papers estimate costs to develop and secure regulatory approval for a GMO to be approximately $150 million and up). A large portion of costs is devoted to the safety and environmental studies that are submitted as part of the regulatory dossiers that must be presented to government agencies. These studies have to be completed under very tight protocols to meet established quality standards expected by government agencies around the world. Most of these studies are conducted by contract research organizations that have a proven and accepted history of high-quality laboratory practice. Because of this high cost, many smaller companies form collaborations to research and develop new GMOs.