With over 30 years of regulatory experience, only Quintiles has the combined expertise to fully understand the specific challenges and needs associated with each filing. We leverage our broad operational and strategic knowledge (e.g. safety, regulatory, biostatistics, etc.) during strategy development and dossier preparation as well as in post-filing support. Tapping into this integrated expertise allows us to appropriately package and present all the information necessary to allow regulatory authorities to make the right decision.