Pre-IND Support:

• Explanation of CBER expectations and policies
• Review of pre-clinical product development
• Guidance on CBER interactions and meetings
• CMC guidance
• Pharm/Tox guidance

IND Support:

• Review/Evaluation of pre-clinical data
• Assistance in clinical trial design
• Assistance in preparation for pre-IND meeting
• IND preparation and review
• Assistance in responding to CBER questions
• Assistance in preparation of IND amendments and annual reports

BLA Support:

• Review and evaluation of clinical and manufacturing data
• Assistance in preparation for pre-BLA meeting
• BLA preparation and review
• Assistance in responding to CBER questions

Biologic Orphan Drug Applications

Biologic Drug Master Files

Page Updated: September 28, 2006