What Are We All About?
We have relied on for our regulatory expertise throughout the entire life cycle from discovery to launch that is expanding our footprint in immunology, neurology, fertility and endocrinology, and oncology. We are progressing through a strong pipeline with more than 20 projects in development, including potential new oncology and immuno-oncology projects.
Our functional groups consist of:
1. Global Research and Development Strategy (Regulatory CMC; Regulatory Oncology & Immuno-Oncology, and Immunology & Neurology)
2. Approvals and Launch Strategy, Life-Cycle Management, & Product Maintenance (Labeling, Ad, and Promo; Launch Management, Market Products)
3. Regulatory Operations (Project and Submission Management; Application and Data Management; Outsourcing and Vendor Management; Process and Compliance Training)
4. Translational Medicines & Device Strategy
5. Global Regulatory & Scientific Policy (Policy and Intelligence; External and Scientific Policy)

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