Sophisticated machine learning framework to automatize  your regulatory processes


The cune-Distiller – regulatory automation – platform provides a sophisticated machine learning framework that enables the extraction of specific data from unstructured data sources, including documents, web sites and other human readable sources.

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Unique cune-Distiller Benefits

Doc.Type Detection

Import any document type in scope from your DMS or other content source. The system will automatically determine the document type and display the result as editable meta data

Language Detection

Data extraction for 26 different languages and auto detects the correct document language.

Data Extraction

Automatically extract all relevant data from all imported documents within minutes, and displays the result in an easy editable view (example).

Version Comparison

Compare the extracted information to information you already have in your database/dictionaries.

Push/Pull Integration 

The system can be seamlessly integrated into your IT infrastructure. Extraction results can be pushed directly into your target system.

Implement AI Driven Machine Learning solution

Artificial intelligence-enabled software has become state of the art within the life sciences industry. Cunesoft’s cune-Distiller software facilitates automation of cumbersome manual processes with a time and process savings potential of 75% and higher. Our projects reach an ROI within less than 12 months.

Modern technologies such as cune-Distiller use several different extraction strategies in parallel: neural networks, natural language processing, fuzzy logic, and deep learning. When combined the right way, information can be extracted from virtually any electronic document. The results are impressive. In addition reinforcement learning constantly improves the trained algorithms. Regulatory Automation software powered by Artificial intelligence learns what result is expected and improves its settings.

Select Any Combination of Data Mining Libraries

cune-Distiller can be applied to many different business cases, and to many more it can be adapted!

Real life business case #1

Business problem

  • Document Migration for DMS change
  •  Import Affiliate documents from file shares
  •  500,000 documents are non-classified legacy documents
  •  Manual classification would take > 1700days


  • Reduce process time by 90%
  •  Reduce process time from 1700 days to 170 days
  •  Ensure DMS project implementation timelines are met
Real life business case #2

Business problem

  • Constantly increasing trial content
  •  Non-scalable manual process
  •  Unstable eTMF data extraction quality


  • Facilitate a seamless user experience process
  • 5 times faster to automate eTMF artifact identification
  •  Maintain cost level while increasing eTMF output
Real life business case #3

Business problem

  • Preparation for IDMP iteration I deadline
  • Increase compliance overall
  • Data Extraction from SmPC & eCTD M3 documents


  • Ensure compliance with Article 57/xEVMPD
  • Time saving of 297 days via automated processing
    • 1591 SmPC’s (26 Languages)
    • Processing time per SmPC: 30 seconds
    • QA Time per SmPC: 20-30 minutes
Real life business case #4

Business problem

  • European eCTD deadline for elimination of NeeS / CTD
  •  Existing dossier content in various formats
  •  Multiple dossier languages due to National Procedures


  • Extraordinary time savings on data extraction, quality assurance, language identification and document splitting.
Real life business case #5

Business problem

  • > 100,000 Adverse Events reported yearly
  •  Multiple languages / Multiple channels
  •  Non scalable manual process
  •  Compliance risk


  • Reduce process time for daily Adverse Events analysis by 80%
  •  Auto-import Adverse Events data into safety system
  •  Increase compliance
Real life business case #6

Business problem

  • Company Core Data Sheet (CCDS) managed centrally
  • Local labeling content needs to follow CCDS content
  • Multiple languages


  • Constant global labeling content monitor
  • Suggested content correction
  • Expedite content comparison & analysis
  • Reduce compliance and legal risks
Real life business case #n

Business problem

  • Tell us your business problem!
  • Fill the contact form, and we will help YOU!

Business solution

  • cune-Distiller!
Real life business case #7

Use Case Scope

  •  Data Focus: Undesired Effects
  •  Compliance threat due to data discrepancy
  •  Use safety data as training data for extraction models
  •  Analyze delta between SmPC & safety data base
  •  Create data comparison report
  •  Download delta data for data cleaning activities


  • Clean data across systems
  •  Automate process – reduce process time
  •  Increase compliance – ensure data compliance across internal systems
  •  Re-use system configuration for other data cleaning

cune-Distiller Behind Scenes

Our Regulatory automation software – cune-Distiller – enables collection of algorithms that include term libraries, deep learning, neuro-networks, natural language processing, artificial intelligence (AI) – to reach its full potential. Depending on the specific needs for each task, one or multiple techniques get applied. AI technology is very complex and difficult to develop. Cunesoft invested many resources to develop an algorithm which serves the needs of the life science industry. There are many possible use cases for this multipurpose tool.

Our Secret To Your Success

We work very hard to deliver the best results for your project!

  • 20/5 support availability
  • 1h guaranteed response time
  • Technical support services
  • Software adaptation
  • User training
  • Regulatory support services

We understand your needs and created an environment with outstanding and unique regulatory support – we will give you live training via Internet, we will always answer to your inquiry. Just call or write our support as often as needed! And most important – we help you not only with technical questions, but with the overall processes.

Meet Our Management 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!

Rainer Schwarz – CEO

Daniel Koppers – CTO


Jim Nichols – COO

See cune-Distiller in Action!

Request a Free cune-Distiller Software Demo

Experience the Power of Machine Learning