Competence Area

Regulatory Affairs

The healthcare market is experiencing tight innovation cycles. New products are being researched with high levels of investment. New markets open up. New product categories emerge. At the same time the regulatory frameworks like MDR, EMA and FDA are becoming increasingly complex. 

lexoro’s Intelligent-Automation tools help to support the full range of regulatory tasks. We are a perfect productivity partner for the Regulatory Affairs Management.

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Benefits of Intelligent Automation in Regulatory Affairs

lexoro can support your team along all relevant tasks and responsibilities. We deliver tailored automation tools that make your work easier. We free you from routine work and give you tools to monitor and manage the full project cycle.

  • Automate regulatory documents and general contents that are needed across the organization 
  • Automate the methods of filing and tracking
  • Assure the alignment of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice 
  • Generate documentation for several ISO standards
  • Integrate with 21CFR11 and EDC systems
  • Automatically generate audit plans and checklists against applicable standards
  • Generation of audit reports
  • Automatically generate and integrate SOPs across the enterprise
  • Automatically interpret, read and synthesize technical material and to generate clear and concise written documents
  • Evaluation of premarket submissions (510(K) Approval)
  • Automation of conformity reports (CE approvals)
  • Generating the submission documents (eCTD)
  • Compliance of Document Format with the eCTD (ISO 19005-1:2005)
  • Automation of the Declaration of Conformity (DoC)

Cost reduction

Quality increase

Relief for employees

Experts focused on their activities

Standardization of processes

Increase productivity

Get rid of routine work?

Lets 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

Michael Fischbäck

Business Development Consultant

Sign up today for your initial Brainstorming.

Intelligent Automation along the entire Compliance-Chain

We enable all critical areas of the value chain with automated solutions. All regulatory workflows, tasks, documents and forms can be integrated into a highly automated suite. Check out your specific area of interest and get inspired by concrete use-cases we delivered to our clients in the MedTech, Pharmaceutical and Chemical industries.