Automated generation of AMNOG Dossiers

Intelligent Automation is the key driver that not only accelerates the creation and generation of AMNOG Dossiers for one of our globally active pharmaceutical customers. By automating tedious and yet highly standardizable tasks, the overall AMNOG process has taken a significant leap. All of this with classic automation in the form of Robotic Process Automation to transfer data and text to subsequently populate and fill the desired AMNOG Dossiers. lexoro´s degree of automation: about 70% for document creation and generation.

The challenge

In many regulated industries, the approval process for products, drugs or substances is very tedious. Especially in the Pharmaceutical area, AMNOG provides physicians with information about the benefits and possible harm of new drugs before prescribing them to patients, creating a level of transparency. In order to precisely document the benefit assessment and to ultimately be able to properly evaluate the assessment, the AMNOG Dossier with 5 different modules is compiled by the Pharmaceutical manufacturer – all determined by the G-BA.

The problem

  • Very high time expenditure with enormous scope of work
  • Manual collection, modification and distribution of information, text elements, tables from various systems
  • Time-consuming copy & paste tasks, formatting & editing, as well as compilation of different modules
  • Populating relevant information into templates for the AMNOG Dossier with its several modules


Being globally active for several decades, our customer is one of the leading pharmaceutical companies with German origin. The company researches and creates life-changing products in various fields and areas and therefore has the ambition to pursue regulatory obligations in the best possible manner.

The solution: Intelligent Automation for the creation and generation of AMNOG Dossiers

Intelligent Automation is the combination of classic automation (RPA) and Artificial Intelligence components and technologies like Natural Language Processing or Machine Learning. lexoro has optimized these technologies to automatically create and generate AMNOG Dossiers. Where there was tedious and time-consuming standard tasks before – now the lexoro technology automatically copies, populates data, text and tables to intelligently create AMNOG Dossiers with relevant text segments and chapters in no time.

Due to this next-level approach, the customer saves 70% of time in data collection and preparation workflows. Plus: the newly standardized process enables the company´s experts to leave routine tasks behind and concentrate on highly complex analyses and other value-adding activities. All in all a future-proof process to create products that really help people.

The process

After initially choosing or selecting a template or chapter for the AMNOG Dossier process manually, the Intelligent Automation process starts. From a data basis – that can be either uploaded or collected automatically – software robots are able to format, edit, compile, aggregate and generate text sections, segments, or whole chapters. These segments are then used to finally generate the dossier. The last step offers an export in any format for futher processing.

12345lexoro AutomationChoose template or chapterCreation of data basis (upload or collect)Formatting and AggregationTransfer, Filling and PopulationPreview and ExportDocument Generation for AMNOG Dossiers and other documents

1Choose template or chapter

Manual selection of the required template or chapter to be processed or generated.

2Creation of data basis (upload or collect)

Automated collecting and copying of relevant raw data and text from in-house systems (e.g., LIMS, SAP, ELN, etc) or from documents (Word, Excel, XML, etc.) to create a data basis.

3Formatting and Aggregation

Extraction, preparation, completion & analysis of data from various reports, documents, batches, sources & systems.

4Transfer, Filling and Population

Fully automated filling of defined templates & tables with relevant data (e.g., proper formatting, in German, German decimal notation, footnotes, binary and time-to-event endpoints, etc.).

5Preview and Export

Final generation & export of the dossier with completed tables for further manual processing & review.

The benefits for the customer

100% error-free RPA technology combined with AI-supported processes leads to a standardized AMNOG Dossier generation workflow
  • Automatic AMNOG Dossier generation with data preparation – approx. 70% time saving
  • 100% error-free RPA technology with support of AI – individually tailored to you
  • Standardization of workflow – EMA- and FDA-compliant creation of dossier chapters and text segments
  • Problem-free integration of the automation solution into your existing system landscape
  • Fast solution development according to your needs & wishes – directly measurable ROI

The savings potential achieved

4.000 h / 325.000 €
Reduction in work performed per year. Total up to 3 FTE at 70% PQ

Have your savings potential calculated now!

Do you want to write your own success story with the help of Intelligent Automation? Contact our experts for RPA, NLP
and Machine Learning and learn how to accelerate AMNOG Dossiers and how much you can save with the innovative automation of your workflows and processes.

Your contact person

Sebastian van der Meer

Managing Director

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