Cunesoft – Regulatory Processes Done Right

Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our solution has been built to fulfill regulatory needs holistically. Our vision is to keep it as simple as possible while delivering compliance and meeting FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.



Cunesoft GmbH is a provider of regulatory management software and services for all segments within the life sciences industry. Solutions include management of eCTD, xEVMPD, SOP, IDMP data and document management as well as regulatory information management (RIM). Software provisioning is provided as Software as a Service (SaaS). The company is headquartered in Munich (Germany) with international offices in France, US and India. For more information, visit


Cunesoft´s expertise comes from deep knowledge of regulatory processes. That translates into a unique software solution and an outstanding support. Modern technology only has value when applicable to real world challenges. The Cunesoft experts deliver a smart, fast and easy to use solution. A brand new content analysis framework for IDMP data extraction is a good example how Cunesoft uses state of the art software to solve a significant customer challenge.


    • Cune-Distiller
      Designed specifically for Life Sciences, cune-Distiller is built on our Content Analysis Framework and is optimized to enable comprehensive data extraction from large volumes of documents. For IDMP readiness, we have a configuration designed to automatically extract data from SmPCs and xEVPRM messages. cune-Distiller can be used for multiple use cases. With its powerful data export, mining, cleaning and mapping engine it supports uncountable processes.
    •  Cune-IDMP (Regulatory Master Data Management)
      User friendly and comprehensive data management for xEVMPD and IDMP compliance that includes seamless access to external systems such as GSRS, UCUM and EDQM.
    • Cune-eCTD
      Create new or import existing electronic submissions. Prepare and compile eCTD’s, NeeS, VNeeS, and paper CTD’s all in one place.
    • Cune-Track (Integrated registration tracking)
      cune-Track dramatically improves efficiency and effectiveness by providing real-time access to registration status information.
    • Cune-SOP
      The Cunesoft SOP system is a ready to use system for all your SOP needs, covering content creation, collaboration, 21 CFR Part 11 compliant processes and training needs in one platform.

View: Fact sheet