Areas of support and expertise:

• US and EU labeling
• Creating and implementing core labeling (incl. CCSI and supporting justifications for safety labeling changes)
• Designing effective and defensible safety labeling
• Target labeling, labeling development during drug development
• Managing complex labeling and regulatory situations - whether local or global
• Designing efficient and defensible labeling policy and processes
• Supporting regulatory/labeling, pharmacovigilance, medical, clinical, marketing and law departments.