Services
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)