Analyze Data and Trends
Work faster & smarter
Reduce time to health authority (HA) submission
Get away from spreadsheets
Evolve from data entry to information management
Better business process integration
Assign tasks, track progress and get notifications
Your trusted source of global information
Always know about the status of your registration activities
Who we are
Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our software has been built to fulfil 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.
Selected Customer References
cune-RIM convinced us fast by its holistic platform approach.Berry GlobalRegulatory Affairs Manager
We appreciate the quality and work as well with cune-eCTD. That saves many double data entries.AthenexHead of Regulatory
Upgrading our data to better, useful information along with flexible status reports was what we aimed for. cune-RIM delivers much more.HeumannHead of Regulatory
Work smarter and stay compliant
Plan and track your registration activity (incl. submissions) in one place
Get updates on regulatory requirements by each nation
Take advantage of an affordable and predictable subscription-based approach to software
Assign tasks to colleagues and follow their progress
Ongoing support via a 1 hour guaranteed response time
Delivered via Private SaaS which makes validation easy
cune-RIM track record
till return on invest
Empower regulatory teams with information
cune-RIM’s smart workflow capabilities allow you to create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.
SPOR to become EU-wide source of validated pharmaceutical regulatory data
SPOR is the abbreviation for the four domains of master data in pharmaceutical regulatory processes described by the EMA: Substances, Products, Organisations and Referentials.
We are part of the EMA group that is working on the logical data models for PMS and SMS and we are working on the integration of SPOR API’s starting December 15th. We plan to release the integration between SPOR and cune-Distiller as well as SPOR and cune-RIM during the first half of 2018. This will enable auto-coding for cune-Distiller extracted entities as formerly available with the xEVMPD standard terminologies. In addition, cune-RIM platform customers will be able to submit data changes via the API’s to the SPOR databases.
Be on time with your regulatory updates
Plan registrations, submissions, renewals and other activities. Make use of the automatic notification to inform the assigned users about new tasks or send reminders before due date.
Track authority correspondence for all registrations, submissions and products easily within one integrated regulatory information management system.
- Link to existing documentation (SmPCs, variation approvals, etc.)
- Subscribe to reports and set up auto-delivery
- Search for product and submission information
- Search for agency interactions by region/country
Integrated reports and charts support management’s overview of critical renewal dates, current ongoing activities as well as finalized tasks in the last few months. Create reports to gain insight into current activities related to a single product, to a specified region, authorities. Stay a step ahead with the management overview of all regulatory projects within your organization along with the current status.
cune-RIM and V.E.R.A.
Virtual Electronic Regulatory Assistant
…guides first time users through each step of the software
…assists in assigning regulatory tasks across your organization
… helps during creation, reuse and batch product updates
… guides on compliance fulfillment throughout the entire regulatory workflow
…can do even more
Learn by doing
“This leads to a new dimension of user experience and work efficiency.”
Rainer Schwarz CEO Cunesoft