Consulting
In cooperation, as required, with associate consultants with outstanding expertise in the fields of labeling, pharmacovigilance, risk communication, reporting and labeling terminologies, and system evaluation/auditing
Also as "add-on" to non-specialized consulting organizations where labeling-specific expertise is required
Our Policy
Providing exceptional experience and showing solutions respecting the sensitive nature of consulting in the area of labeling
Consulting Areas
- Content and Format of Labeling
- Content and implementation of core data sheets, labeling harmonization
- Supporting rationales and documentation for core labeling changes
- Development core safety information (for IB) and development core data sheets
- Submission labeling for new products/indications
- Designing and testing EU patient labeling
- Complex labeling and regulatory situations - local and global
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Processes, Organization, Policies
- Global labeling system design (process, organization, policies, business rules)
- Setting up labeling departments
- Labeling decision making structure for development products and postmarketing labeling changes
- Designing the interface between safety evaluation and labeling process
- Aligning developmental labeling and IB, incl. development core safety information
- Company-internal control systems for worldwide safety labeling, role and features of Core Data Sheets
- Headquarters-Affiliate interactions
- Labeling quality control systems
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Labeling Support Technology
- Labeling project management systems (management of requests, documentation of decisions, implementation tracking, integration in product knowledge bases)
- Labeling databases and document management systems
- Tracking and auditing systems