To ensure scientific and commercial success, it is critical to understand the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan.
Although the primary purpose of a well-designed regulatory strategy is to assure an efficient process for providing new, high quality and effective drugs for patients, it is also essential to effectively maximize the return on investment.
Each step along the path to commercialization is important and an effective chemistry, manufacturing and controls (CMC) strategy and ensuing communication plan plays an integral role in the overall success of a product.