Intelligent Regulatory Solutions
Machine Learning adapted for Life Sciences
Regulatory, Clinical & Safety Use Cases
Unique Data Mining Engine
Holistic Regulatory Data Model
Sophisticated yet simple to use
Delivered as Private SaaS or On-Premise
- Designed for Life Sciences companies
- Pre-configured IDMP Iteration 1 Library
- Data mining and data cleaning from SMPC´s, xEVMPD´s, eCTD´s
- Sophisticated yet simple to use
- Built on industry best practices
- Delivered as private SaaS or on premise
Machine Learning Powered Regulatory Automation
Meet the Cunesoft software suite
Create new or import existing electronic submissions and compile all types of eCTD submissions including eCTD lifecycle management.
Manage Standard Operating Procedures (SOP’s) from beginning to end. Distribute to employees and automatically track training records. read more
Create your own submission data base, track all regulatory events and include authority correspondence in one comfortable system.
Meet Our Managment Team
Deep knowledge of the life science industrie and excellent regulatory understanding makes them 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.
Rainer Schwarz – CEO
Daniel Koppers – CTO
Jim Nichols – COO
Benefits for our customers
What makes our software stand out
for Pharma and Life Science Industries
Creating, editing and migrating submissions is easy with our eCTD module in combination with the Regulatory Document Management Module. Managing your ASMF, DMF and other Sumbission types was never easier! Moving from paper to electronic submissions is quick and easy with the Cunesoft regulatory suite!
Producers of originator drugs or Biotechnology companies face the challenge to reduce R&D time as much as possible. Electronic submissions to gain market approval by authorities can securely be handled by Cunesoft’s eCTD Module in combination with the Regulatory Document Management Module. Ideal for Biotechnology companies to manage quality compliance can be provided with Cunesoft’s lean SOP management software.
Regulatory service providers in most cases cannot afford hosting regulatory software for electronic submissions, quality management and clinical trials management. On the other hand their customers require results that have been created under regulatory compliance aspects. Cunesoft’s online Software as a Services (SaaS) concept provides an ideal base to manage compliance and offer their customers a collaborative platform to manage regulatory documents, electronic submission types such as eCTD’s and share quality documents such as SOP’s with them.
Stay up to date with industry news and regulatory events
Happy Customers With Cunesoft
Selected customer references
I highly recommend Cunesoft products and the entire Cunesoft team. They actually listen to customer feedback, as was evidenced by the last software release.HeumannSenior Regulatory Officer
We have been using cune-eCTD for quite some time now and it has become even more impressive when combining it with cune-RDMS and cune-Track. The virtual assistant (VERA) makes the software even easier to use!AthenexRegulatory Affair Specialist
The Cunesoft solutions are relieving our staff from paperwork requirements whilst meeting EMA and FDA guidelines on compliance. The sophisticated software copes with a huge amounts of information from different sources and we're building information that is reliable and accessible. We're now looking at how we can further expand Cunesoft into other areas of the company.AvacarehealthSenior Regulatory Strategist
IDMP is a challenge Cunesoft is helping us to overcome. We are intrigued by the power of cune-Distiller and the quality and speed of the data output. Right now we evaluate how this method of data collection could be potentially used in other use cases across the company.Astra Zeneca Senior Regulatory Manager
The Cunesoft online software for electronic submissions and document management is ideal for regulatory consultants such as myself.Anja KarstensRegulatory Manager - ak MDRA
By running cune-Distiller, we have been able to achieve a dramatic breakthrough and the end result is a much needed value proposition for IDMP data gathering: improved quality at reduced costs.GSKRegulatory Affair Content Specialist
“Your regulatory affairs role is vital to the development, registration and marketing of all drug products. Cunesoft’s role is to help you manage regulatory activities in the most efficient way possible. Our world needs your products quickly. Let’s work together to achieve this.”
Rainer Schwarz – CEO and Founder, Cunesoft