We like to use the analogy of comparing our services to that of a lawyer. If you are going to court, you can certainly try and defend yourself and you (potentially) could present a good case for yourself. By using a lawyer, you are hiring a specialist who has specific expertise to improve your case or your defense and can significantly increase your odds of winning a case. Just as a lawyer cannot guarantee a successful outcome to your case, we cannot guarantee a product approval. What we can do is use our skills and expertise to prepare the best possible submission that greatly increases your chances of approval. Because we prepare so many regulatory submissions each year, a DSA Regulatory Affairs Consultant has the ability to predict with greater certainty how the regulators will receive and review your submission. You benefit from the submission comments that we have received from other regulatory projects and we can address those submission deficiencies before your submission is even filed.