Regulatory Automation Software

Sophisticated machine learning framework to automatize  your regulatory processes

The PhlexNeuron 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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PhlexNeuron 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

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Language Detection

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

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Data Extraction

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

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Version Comparison

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

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Push/Pull Integration 

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

PhlexNeuron Must Have Solution

Implement an AI-Driven Machine Learning Solution

Artificial intelligence-enabled software has become state of the art within the life sciences industry. PhlexNeuron 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 PhlexNeuron 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.

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Select Any Combination of Data Mining Libraries

PhlexNeuron can be applied to many different business cases, and to many more it can be adapted!



Document Classification

DMS Migration / Document Type Detection / Meta Data Extraction / Identify Primary and Sub Document Types / Leverage DMS Reference Model / Reduce Manual Efforts and Errors

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


eTMF Automation

Autoclasify Artifacts / Extract Artifact Attributes / Automate Trial Content Analysis / User-Driven QC Process

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


Regulatory Compliance

SmPC data extraction / Article 57/xEVMPD / Automation Submission / Increased Compliance / Reduced Manual Efforts

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


Submission Conversion

Document Splitting / Analyze Legacy Submission Content / Apply CTD Granularity / Identify Document Splitting Rules / Automatically Split Documents / Reduce Manual Efforts and Errors

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.


Adverse Events

Auto Identify Severity / Extract Indications / User-Driven QC Process / Integrate Saftey System

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



Compare Core Data Sheet (CCDS) Compliance / Align CCDS to Affiliate Labeling / Ensure Global Data Governance / Measure via KPI's / Stay in Compliance 

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

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.


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

It's time to Raise Your Standard

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PhlexNeuron: Behind the Scenes

PhlexNeuron 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. Phlexglobal 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.


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It's time to raise your standard 

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