Drug development

Scientific and Regulatory Strategies

• Regulatory guidance and management in all phases of product development and regulatory submissions
• Development and coordination of worldwide objectives
• Product feasibility research and analysis
• Guidance for responses to warning letters, inspections, clinical events, etc.
• Guidance on orphan drug designations
• Guidance on fast track designations
• Information research and expert opinion reports
• Liaison activities with regulatory agencies
• Organization of, preparation for, and participation in meetings with regulatory authorities
• Access to a broad network of specialized regulatory experts