https://www.youtube.com/watch?v=43ngkc2Ejgw&list=PLGmxyVGSCDKvmLInHxJ9VdiwEb82Lxd2E&index=6
Manage Your Regulatory Information With Ease

cune-RIM

Are you looking for an easy to use and intelligent Regulatory Information Management solution? cune-RIM will dramatically improve compliance with efficient and effective real-time access to your global registration information.

regulatory information management

We Are Here To Help

cune-RIM is designed to solve your regulatory challenges

  • Outgrowing spreadsheets
  • Information are stored in multiple sources
  • Use of different software solutions which do not work well together
  • Growing number of products or distributing markets
  • No workflow automation
  • No task assignment
  • Difficulties in tracking changes in country-specific requirements
  • Different global approach to data collection

With cune-RIM these challenges are all in the past now.

Regulatory Information Management: Unique Benefits

At Cunesoft, Your Investment In Our Solution Equals Our Investment In Your Success!

Work Faster & Smarter

Reduce time to health authority submission

Get Away From Spreadsheets

Evolve from data entry to information management

Better Business Process Integration

Assign tasks, track progress and get notifications

Single Source of Global Information

Always know about the status of your registration activities

Like Nothing You’ve Seen Before

A Picture Is Worth A Thousand Words… Watch Our Video

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Status Information

Manage the lifecycle of pharmaceutical product registration activities. Get extensive status information and use the alert management which is included in all workflows.

Analyze Data and Trends

Illustrate reports using standard reports (graphical, tabular and with map visualizations) or design your own reports. Our Regulatory Information management’s smart workflow capabilities allow you to create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates. The software helps you with creation, reuse and batch product updates.

Plan Accordingly

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.

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.

Meet Our Managment Team

Deep Knowledge Of The Life Science Industry And Excellent Regulatory Understanding Helps Us Deliver Regulatory Peace Of Mind

 

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.

Contact us
CEO Cunesoft

Rainer Schwarz – CEO

Daniel Koppers – CTO

COO

Jim Nichols – COO

SPOR Picks Up Speed In 2018

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  our Regulatory Information Management 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.

Download the Onepager "Spor - An Overview"

Become A Member Of The Cunesoft Family

Over 500 Active Users Love Our Compliance Software Tools.

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

AthenexHead of Regulatory

cune-RIM convinced us fast by its holistic platform approach.

Berry GlobalRegulatory Affairs Manager

Upgrading our data to better, useful information along with flexible status reports was what we aimed for. cune-RIM delivers much more.

HeumannRegulatory Specialist
RIM Software

Work Smarter and Stay Compliant

Use the advantage of intelligent software supporting your daily work

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

 Download Important Information For Free

Purchasing Professional Software Should Be A Fact Based Decision.

We Deliver Regulatory Peace Of Mind

We Are Driven By Our Desire To Be A Reliable Partner To Our Customers

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

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.

ASK FOR MORE INFO
regulatory information management

 What We Have Achieved With cune-RIM

Track Record

over

500

users

over

2000

managed submissions

less than

3 weeks

 implementation time

less than

3 months

until return on investment

Meet Your Build-in Assistant 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 
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.

 

Request a Free Software Demo

Regulatory Information Management

Experience the Power of cune-RIM in a Call with our Regulatory-Experts

VERA…

Regulatory Information Management
Key  Challenges

Key challenges of Healthcare Regulatory Compliance can be unlocked with our cune-RIM solution!

Ask yourself: Do I have problems with:

  • xEVMPD Management
  • your submissions planning and tracking
  • dossier management

and other hurdles?  Have a look at our “Key Challenges Point to a RIM Solution” and learn how Cunesoft’s Regulatory Information Management solution cune-RIM can help you to defeat such obstacles and reach a new level of healthcare regulatory compliance – regulatory peace of mind.