Fact Flyers related to Regulatory Affairs and CMC
PharmaLex offers full lifecycle management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA) and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including electronic Common Technical Documents (eCTD), and Structured Product Labeling (SPL).
Meetings with the leadership and review staff of the US Food and Drug Administration (FDA) are one of the most important resources available to sponsors seeking agency approval in the US. PharmaLex recommends holding face-to-face and teleconference meetings with FDA throughout the product development timeline.