About
Quark empowers the world’s largest pharmaceutical companies to automate the production of their highly regulated or complex documentation, so they can approve and publish it faster, and stay compliant. It enables them to accelerate regulatory approvals, release the bottlenecks around content collaboration, and get their drugs to market in record time. Quark Publishing Platform (QPP) NextGen, the cloud-based, AI-powered component content management system (CCMS) with native XML-based structured authoring using Microsoft Word, helps pharmacovigilance teams centralize and simplify the processes involved in co-authoring and approving the PV system’s critical drug safety documentation. This starts with the master file (PSMF) and traverses through all aggregated and regulatory affairs reports, including development safety update reports (DSURs), periodic adverse drug experience reports (PADERs), periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and risk management plans (RMPs).