Rely on Us To Attend to All of Your Regulatory Needs
B&H manages more than 50 active clients as US or Regulatory Agent.
B&H has successfully prepared, submitted, and received approval for numerous NDAs, BLAs and ANDAs.
B&H has participated in defining strategy and has coordinated and participated or led more than 400 face to-face or teleconference meetings with FDA (~15 annually).
B&H successfully prepares and submits 8-12 INDs annually.
B&H prepares more than 175 annual reports annually.
B&H has successfully prepared, submitted, and obtained Fast Track, Breakthrough Therapy and Orphan Drug Designations, and negotiated and received Accelerated Approvals.
B&H has processes in place to ensure efficiencies in the lifecycle management of our clients’ applications.