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Services

Consultancy & Training

SORAPEX offers consultancy on Regulatory Affairs (RA) labeling topics:

  • Labeling organization, processes, policies and tools
  • Labeling compliance for inspections and audits
  • Labeling alignment projects
  • Optimization of Core labeling (CCDS or Master SmPC)
  • Regulatory Intelligence

SORAPEX offers training options for performing Regulatory Affairs (RA) labeling related activities:

  • Customized training on expert labeling topics
  • Specialized training of RA labeling staff
  • Labeling training for all staff

Project Management and Support

SORAPEX manages and/or provides support in the following areas:

  • Provide expertise in EU labeling (SmPC content, format)
  • Design and implement core labeling
  • Ensure compliance with current EU regulations, guidance and templates
  • Compile packages (competitor labels, class labeling, relevant guidelines etc) for internal and external discussion
  • Assist with preparation, maintenance, and finalization of labeling texts for internal review before submission to regulatory authorities
  • Liaise with Readability Testing company
  • Monitor compliance with labeling SOPs and working practices