Mary Ellen has extensive experience in product development planning, global registration strategy development, worldwide product registration in a variety of therapeutic areas and modalities, and successful FDA and global health authority interactions. In addition, she is recognized as an expert in preclinical development and is an American Board of Toxicology certified toxicologist. Click here to read Mary Ellen's bio.
Areas of Expertise:
Areas of Expertise:
- Product Development Planning
- Regulatory Strategy
- Agency Meetings & Correspondence
- Pharmacology/Toxicology Development
- Advisory Committee Meetings
- Due Diligence
- Emerging Markets
- Preparation of Regulatory Documents and Applications