The Pulse of A.I.

Intelligent Automation in highly regulated industries

We automate regulatory tasks and workflows along all areas of the product life cycle. Our solutions help you to reduce knowledge intense document work by more than 300%. We offer pre-configured components, individual project-solutions and expert support in our core industries: MedTech, Pharmaceutical and Chemicals. Find out how you can leverage your specific use-case through RPA and AI.
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Trusted by leading companies worldwide

Bayer
Hartmann
Brainlab
Zeiss
DZNE

Our Use Cases

Explore the ways automation can help your business

Benefits for our customers

MedTech

Intelligent Automation for Medical Device Registration Workflows

Regulatory or Clinical Affairs. Quality Management and Assurance. Product Safety, Risk Management and Post Market Surveillance. All these departments ...

Regulatory or Clinical Affairs. Quality Management and Assurance. Product Safety, Risk Management and Post Market Surveillance. All these departments and competences have to work hand in hand when it comes to the registration process for medical devices and products. Within the medical device industry and other regulated industries it is incredibly important to document, report, and monitor everything that is going on and happening during a product life cycle. Intelligent Automation supports this entire life cycle in documentation and reporting with powerful components and technologies. Often achieving an automation level of 70%.

lexoro has been developing and delivering successful solutions for well-known medical device companies for over 20 years, accelerating their registration and regulatory workflows in various fields. Read more about our solutions here.

Pharmaceutical

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 pharma...

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.

Pharmaceutical

Intelligent Automation for Pharmaceutical Registration Workflows

Regulatory, Clinical, or Medical Affairs. Drug or Product Safety. Quality Management and Assurance. Risk Management and Post Market Surveillance. All ...

Regulatory, Clinical, or Medical Affairs. Drug or Product Safety. Quality Management and Assurance. Risk Management and Post Market Surveillance. All these departments and competences have to work hand in hand when it comes to the registration process for drugs and medicines. Within the pharmaceutical industry and other regulated industries it is incredibly important to document, report, and monitor everything that is going on and happening during a drug life cycle. Intelligent Automation supports this entire life cycle in documentation and reporting with powerful components and technologies. Often achieving an automation level of 70%.

lexoro has been developing and delivering successful solutions for well-known pharmaceutical companies for over 20 years, accelerating their registration and regulatory workflows in various fields. Read more about our solutions here.

MedTech

Automated population & creation of the Summary of Safety and Clinical Performance

The Medical Device Regulation (MDR) has brought several obligations and requirements regarding reporting, safety, and other risk-preventive actions. T...

The Medical Device Regulation (MDR) has brought several obligations and requirements regarding reporting, safety, and other risk-preventive actions. These processes and the effort that comes with them, has left a lot of companies struggling with the regulatory workflows. The Intelligent Automation solution by lexoro helps our clients in the medical device sector to accelerate the preparation, the population and the generation of chapters and sections within the Summary of Safety and Clinical Performance (SSCP). This way, the workload for these summary reports – obligatory for Class III and implantable devices – can be reduced significantly. lexoro´s big performance-plus: a degree of automation of about 70%.

Pharmaceutical

Intelligent Automation for Benefit Assessment & AMNOG

For a leading European company providing medicines and care, lexoro developed a solution to automate the benefit assessment for pharmaceuticals. By us...

For a leading European company providing medicines and care, lexoro developed a solution to automate the benefit assessment for pharmaceuticals. By using Intelligent Automation to search databases and evaluate the results, this solution accelerates the whole assessment workflow. The benefits: The intelligent solution serves the customer significant time savings for tedious standard routines as well as automatic output of the results in a standardized list. In conclusion, the database search and evaluation or assessment process is highly accelerated by focussing on relieving the top experts.

Pharmaceutical

Automated generation of Common Technical Documents and its Modules

Intelligent Automation is the key driver that not only accelerates the creation and generation of CTD Modules, Overviews and Summaries within a global...

Intelligent Automation is the key driver that not only accelerates the creation and generation of CTD Modules, Overviews and Summaries within a globally active pharmaceutical group. It also empowers the highly competent experts by automating tedious standard tasks and time-consuming copy & paste routines. This way, the generation of reports, documents and other mandatory parts of the Common Technical Document is taken to a new level with time savings and a degree of automation of about 70%.

MedTech

Automated creation of Clinical Evaluation Reports

For one of the world’s leading medical technology companies which offers innovative products and services in Medical and Surgical, Neurotechnolo...

For one of the world’s leading medical technology companies which offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine lexoro automated the creation of Clinical Evaluation Reports (CER). For our client we automated the creation of Clinical Evaluation Reports by copying, preparing & populating text & tables to speed up process cycles and tedious workflows using RPA and NLP technology. With the Intelligent Automation of the workflows we achieved a degree of automation and therefore time savings of about 70%.

PharmaceuticalMedTech

Automated creation of PSUR and PMSR

For an innovative global healthcare company lexoro automated the creation of Periodic Safety Update Reports (PSUR) and Post-Market Surveillance Report...

For an innovative global healthcare company lexoro automated the creation of Periodic Safety Update Reports (PSUR) and Post-Market Surveillance Reports (PMSR). The Intelligent Automation included automated data preparation as well as the automated collection and preparation of information which is then automatically entered into the template structure of the PSUR and PMSR, thus replacing time-consuming copy & paste tasks.

Pharmaceutical

Automated creation of Clinical Study Reports

For one of the world’s leading research-driven pharmaceutical companies with 130 years of experience lexoro automated the creation of clinical s...

For one of the world’s leading research-driven pharmaceutical companies with 130 years of experience lexoro automated the creation of clinical study reports (CSR). The Intelligent Automation contained 25.000 pages of medical writing, automated copying & filling of data, text and tables into the respective chapters from the Clinical Study Protocol (CSP) into the Clinical Study Report (CSR). Intelligent Automation of lexoro has freed the experts from many small tasks with little requirement and in addition, tables can be analyzed using Data Science and descriptive texts can be written using NLG.

MedTech

Intelligent Automation for Clinical Evaluation

For a leading European provider of system solutions for medicine and care lexoro optimized the regular monitoring of medical devices with the applicat...

For a leading European provider of system solutions for medicine and care lexoro optimized the regular monitoring of medical devices with the application of Robotic Process Automation (RPA) database crawlers. The benefits: The intelligent automation of a standards-based process brought the customer significant time savings as well as automatic output of the results in a standardized list. In addition, the highly qualified employees can devote themselves to more specific tasks.

Pharmaceutical

Automated creation of Product Quality Reviews

The Intelligent Automation of the creation of product quality reviews for a leading manufacturer of high-quality Pharmaceuticals was a challenge lexor...

The Intelligent Automation of the creation of product quality reviews for a leading manufacturer of high-quality Pharmaceuticals was a challenge lexoro gladly accepted. Quality assurance meant a very high time commitment for the client, often an entire team did this task full time with annual review required.

Our Services - it´s essential to move now!

Specific industry knowledge and deep process understanding combined with a high demand for technology and effectiveness. Time of transformation: Business models in flux – the digital revolution is constantly changing workflows and market mechanisms. We support you in making the best possible use of your opportunities, strengthening competitive advantages and ideally exploiting the versatile possibilities of AI and automation.

Intelligent Automation Services

We automate processes and workflows in regulated environments using cutting-edge technologies and Intelligent Automation.

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Business Consulting Services

We offer quick and straightforward expert support concerning business areas of Regulatory Affairs, Quality Management, Regulatory Affairs, Production, R&D and IT – to the point and tailored to your project and needs.

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Software-Implementation-Services

We provide you with expertise concerning project & solution management, DevOps & SRE services, software development as well as Computer System Validation – customized to the requirements of regulated industries.

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We offer high-impact solutions with a quick ROI

Reduction of the costs

Quality increase

Relief for the employees

Experts focused on their activities

Standardi­zation of processes

Increase productivity

Get rid of routine work?

Let´s talk about it. Our Solution Experts can give you further insight into Intelligent Automation options along the entire Compliance-Chain.

Let BOTs and A.I. help you in time-consuming tasks and refocus your time on real quality work.

Tell us about your wildest automation wishes – and we turn them into reality!

Your contact person

Sven Kolthof

Managing Director

Sign up today for your initial Brainstorming.

The lexoro Focus

We have been working on the automation and digitization of critical business processes for more than 20 years. In doing so, we have always focused on the following triad: technical excellence (RPA and A.I.), process knowledge (regulated workflows) and industry expertise (MedTech, Pharmaceutical, Chemical).

Intelligent Automation

AUTOMATION
RPA

Robotic Process Automation

Software Robots (BOTs) automate time-consuming, routine tasks along all stages of the product life-cycle. Regulatory documents, reports and workflows are integrated end-to-end across all enterprise platforms.

Read more about RPA

ARTIFICIAL INTELLIGENCE
NLG

Natural Language Generation

NLG is a subfield of Artificial Intelligence and deals with the automated generation of natural language texts through software. The technology can create dossiers, studies, reports and compliance documents in all areas.

Read more about NLG

NLP

Natural Language Processing

A.I. based technique that helps to understand the contents of documents, including the contextual nuances of the language within them. The technology can accurately extract, categorize and classify all kinds of regulatory related contents.

Read more about NLP

ISM

Industry Solution Maps

Solution Maps are task- and process-specific modules that integrate with lexoro’s Intelligent Automation suite. The Solution Maps address all regulated tasks, documents and reports along the industry-specific product life cycles.

About lexoro

We automate your compliance projects along all stages of the product life cycle. Our Solution Maps offer a suite of well designed use cases – centered all around industry specific regulatory demands. From Regulatory Affairs and Clinical Trials to Quality Management, Post-Market Surveillance and Risk Management. We help you turn data from multiple sources into complete compliance solutions. Fully automated. To speed up time to market.

Let BOTs do the routine work

Our process

Learn more about our process

Would you like to optimize your processes?

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and savings potential for your project.
We look forward to getting to know you.

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    Your contact person

    Sebastian van der Meer

    Managing Director