Regulatory Affairs
APCER’s Regulatory team support their clients in entire lifecycle of drug Product in all major markets – US, Canada, EU and UK. We provide strategy, prepare & compile all kind of submissions in the development phase, marketing authorization phase and Life Cycle Management. Our Regulatory Affairs team helps clients with product selection, filing strategy, and approach, performing all the necessary regulatory activities throughout the lifespan of a product. We have Regulatory CMC expertise and work together with our Regulatory Medical Writers to address review and writing requirements of our clients for their high quality submissions.