Regulatory Support

• Liaison to Regulatory Authorities
• Interactions with Regulatory Authorities regarding project-specific issues or current position on certain issues
• Interactions with Regulatory Authorities to coordinate current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) FDA inspections, including follow-up correspondence and documentation
• Meetings with Regulatory Authorities regarding drug development programs (i.e., pre-IND, end-of-Phase 1 and 2, pre-NDA, and Advisory Committee meetings), including meeting organization, information package preparation, and meeting management
• Regulatory guidance at all stages of product development