Integrated registration tracking

cune-RIM can dramatically improve compliance with efficient and effective real-time access to your global registration information.

Cune-rim software
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Status Information

Analyze Data and Trends

Plan Accordingly

Management Reports

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.

HRA PharmaRegulatory Affairs Manager

We appreciate the quality and work as well with cune-eCTD. That saves many double data entries.

PolymedHead 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

Manage and plan registration activities:

Plan and track your registration activity (incl. submissions) in one place

Stay on top of things:

Get updates on regulatory requirements by each nation

Save money:

Take advantage of an affordable and predictable subscription-based approach to software

Empower your team:

Assign tasks to colleagues and follow their progress

We are here for you:

Ongoing support via a 1 hour guaranteed response time

Work confidently:

Delivered via Private SaaS which makes validation easy

cune-RIM track record

over

users

 

over

Managed submissions

less than

3 weeks

 implementation time

less than

3 months

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.

  • Analyze data and trends (graphical, tabular and map visualizations)
  • Creation, reuse and batch product updates
  • Standard reports plus design your own reports
Cune-RDMS
Best-SOP-software
  • Lifecycle management of pharmaceutical product registration activities

  • Extensive status information

  • Workflows including alert management

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.

Learn more with our overview document:

SPOR - An overview

Contact us now and prepare for upcoming deadlines

Request a Demo                                   Trial Version

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
Submission-Planning-Screenshot

Management Reports

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

 

Vera …guides first time users through each step of the software. …assists in getting documents stored in the correct folders … helps to prepare an eCTD submission. … guides on compliance fulfillment throughout the entire regulatory workflow …can do even more 

VERA…

…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

Contact us and enjoy a FREE Demo

Request a Demo                                   Trial Version