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Guidance & Training

SORAPEX offers advice, planning and information on Regulatory Affairs 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 to enable performing Regulatory Affairs labeling related activities:

  • Identification of qualification deficiencies and training needs
  • Customized training for supporting and expert labeling staff
  • Mentoring for labeling management
  • Standardized training program for labeling staff
  • General labeling information and awareness for all affected personnel

Project Management and Support

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

  • Provide expertise in EU labeling (SmPC content, format)
  • Design and implementation of 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
  • Short-term substitution of labeling employees (sickness, holidays, quitting)