Help regulatory authorities make the right decision
You know your product’s story and have confidence in the data. And you have no doubt the product will make a difference in the lives of patients worldwide. But you need to ensure that regulatory officials have all the information they need to come to the same conclusion, even after a lengthy and complex registration process.
A comprehensive approach helps tell your product’s strongest story
No product’s story is one-dimensional, and its dossier shouldn’t be, either. Our integrated team of medical writers, biostatisticians, regulatory specialists and subject matter experts work together to develop a thorough filing plan that includes all of the data needed for proper analyzing, interpretation and packaging. From early engagement and planning to post-filing support, we work with you across global markets to increase efficiency, decrease risks to quality and achieve a successful dossier.
Time, energy and money have been invested in your product. Launching it on time brings the most value for a better return on your investment. Quintiles’ integrated approach to product registration and filing clears the path to approval and success.