Quark Software Inc.

Exhibitor

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). 

Powered by Microsoft Azure OpenAI and connected with wider content and business software ecosystems such as Veeva and ArisGlobal, QPP NextGen manages every stage of the authoring and review lifecycle from end to end. PV teams increase productivity and save time by easily writing, importing, formatting and publishing complex types of variable global content to omnichannel submission outputs using structured, XML component-based authoring workflows, stringently tracking workflows in real time, driving risk reduction and safeguarding compliance.  

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