Knors Pharma approach to regulatory affairs due diligence is to match regulatory expertise with scientific, clinical, nonclinical, and overall drug development expertise to support marketing approval and market acceptance. Knors Pharma team of regulatory affairs professionals understand the statutes, key regulatory opinions, and procedures that make for successful interactions with regulatory authorities like the FDA. However, we also realize that this expertise is not enough. Equally important is the ability to generate well-written and succinct arguments that are grounded in proven scientific, regulatory, and overall drug development principles.