Regulatory Affairs Solutions (RAS)

Data retrieval and extraction from unstructured medical data is highly relevant in regulatory processes and marketing analysis

Information to extract:
  • Product name
  • MA-number, -holder, -date
  • Composition
  • Indication
  • Procedure & CMS
  • Legal basis
  • Prescription status
  • Smart Text Extraction from unstructured data using natural language processing methodologies (NLP) 
  • Data and information from uploaded documents are automatically extracted and classified. 
  • Results can be reviewed, revised and approved by users. Subsequent reporting requirements can be highly automated in customised and fully validated solutions.
  • Key benefits are substantial time savings through increased automation and superior intelligence insights used for marketing & portfolio analysis.
  • LVV has supported regenold GmbH in the development of NLP based algorithms. Currently in final product development before market launch

Use Case Examples:

  • Market overview for regulatory strategy
  • Harmonization and/or comparison of patient information
  • Company core datasheet
  • PV/PMS compliance data overview
  • PV/PMS country overviews and oversight reports
  • Various reporting requirements