The document describes a regulatory software system that: 1. Manages regulatory activities and tracks progress for product registrations across countries. 2. Produces regulatory summaries and creates tasks for registration and lifecycle management activities. 3. Generates alerts when tasks are late and tracks agency correspondence.

1. Plans regulatory activities & tracks progress for all registrations and products across all countries and regions.
Produces electronic regulatory product intelligence that provides current, comprehensive regulatory summaries.
Creates regulatory tasks starting with new registrations through to lifecycle management activities. Enables affiliate engagement
and allows for task delegation to other team members.
Generates alerts when tasks are not finished within agreed timeframes and indicates which are potentially adding risk to
submission timelines.
Tracks and archives authority correspondence for all submissions and products within one integrated regulatory content
management system.
Manages post-marketing registration activities that are required and allows for the creation of submission backbones with eCTD
module.
Publishes helpful reports with real-time information on the status of registrations, upcoming renewals and agency interactions in
various countries and across products. Reports can be generated using a variety of filters from XEVMPD and IDMP criteria.
Facilitates setting and tracking of KPIs related to regulatory projects.
Better compliance
Improved efficiencies
Global availability
xEVMPD and IDMP-ready
Advantages:
About Cunesoft: We offer a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our software
has been built to fulfill regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering
compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
Cunesoft, Inc.
Princeton, NJ
Phone: +1 (609) 955 3468
Cunesoft GmbH
Munich, Germany
Phone: +49 (089) 235 14741
www.cunesoft.com