Consulting - Training - Labeling Services
Regulatory Support - Research - Auditing
Assisting pharmaceutical companies and other organizations in evaluating, developing, implementing and managing:
- Healthcare professional information
- Patient / consumer information
- Labeling systems, processes, organizations and technology
Providing expertise in:
- US and EU labeling (content, regulatory aspects, format)
- Designing and implementing core labeling (incl. Development Core Safety Information)
- Designing effective and defensible safety labeling
- Managing complex labeling and regulatory situations - whether local or global
- Designing efficient and defensible regulatory / labeling processes, organizations and systems
Supporting regulator/labeling, pharmacovigilance, medical, clinical, marketing and law departments
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