PharmaLex US Corporation
Associate Industry Clinical & Regulatory Strategic ConsultingWoburn, MA
PharmaLex US Corp. provides integrated drug development support through a complete range of US regulatory services such as FDA meeting preparation, regulatory strategy, electronic publishing and submissions, regulatory CMC writing or review, FDA labeling / promotional support, responses to FDA letters, and project management, quality management and compliance, pharmacovigilance, epidemiology and risk management ... all provided from experienced industry leaders. We have years of experience in interacting with FDA....from pre-IND to market approval and throughout the lifecycle management process. Our expertise spans all therapeutic areas. With offices in the US including Woburn, MA as well as offices in 22 countries, we offer a local presence but can also prepare seamless, integrated US and EU (and global) regulatory strategies for your development projects as a one-stop regulatory solution. This could result in significant synergies and faster development timelines for you.