Intelligent Regulatory

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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

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is now


Our Regulatory Compliance Software Suite:

  • 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 Regulatory Compliance Software Suite



Regulatory master data management for the preparation, management and submission of ISO IDMP compliant and xEVMPD submissions.
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Create, review, approve and sign submission related documents according to FDA 21CFR part 11 requirements. read more


Create new or import existing electronic submissions and compile all types of eCTD submissions including eCTD lifecycle management.
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Manage Standard Operating Procedures (SOP’s) from beginning to end. Distribute to employees and automatically track training records. read more

Cunesoft RIM Software


Create your own submission data base, track all regulatory events and include authority correspondence in one comfortable system.
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Automatically extracts data from SmPCs and xEVPRM messages. Detailed data elements about the medicinal product name, clinical particulars, package medicinal product and marketing authorization are automatically extracted from uploaded input files. read more

Meet Our Management Team

Deep knowledge of the life science industry 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 software 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.

Contact us
CEO Cunesoft

Rainer Schwarz – CEO

Daniel Koppers – CTO


Jim Nichols – COO

Benefits for our customers

What makes our software stand out

Regulatory has never been easier

– with our Regulatory Compliance Software Suite

Tailor-made solutions

for Pharma and Life Science Industries 

cune ECTDCreating, 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  compliance software suite!

ectd software supportProducers 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.

SOP SoftwareRegulatory 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.

regulatory softwareShould you require help to produce your premarket notification 510(k) or the premarket approval (PMA) as eCopy then our outsourcing service team can help you. Furthermore the Cunesoft SOP and Training Records Management module are ideal to manage quality processes according to GMP and GDP requirements.

Cunesoft News

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

Demo request

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