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Carolyn Hoskins Kruse, Founder

Summary:

• Extensive experience in multinational pharmaceutical development
  
• International and US regulatory affairs including submission preparation and regulatory strategy for small molecules
• Biologics, vaccines, veterinary products
• Drug device combinations
• Pharmaceutical manufacturing
• Technology transfer and project management
• Conduct audits of preclinical
• Clinical and manufacturing sites for GMP, GLP and GCP compliance
• Conduct of integrity audits of information submitted to regulatory agencies
• Proven leadership, organizational and presentation skills combined with strong technical and academic achievement
• Proven ability to work effectively with project teams and diverse company and country cultures
• Extensive experience with preparation for and conduct of FDA and EU regulatory agency meetings covering CMC, preclinical and clinical issues
• Experience with US and EU pediatric and Orphan Drug applications
• Experience with applications for multiple therapeutic areas including CNS, oncology, cardiovascular, dermatology and dental, and others

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