We frequently give this presentation to new clients, to let them know what to expect when planning a submission. Topics of this conversation include:

• Strategy and planning
• Specifying project deliverables
• Production and QC of analysis datasets and TFLs
• Evaluation of project deliverables
• Assembling and auditing the data submission
• Fielding FDA requests
• 120 Day Safety Update
• Preparing for the Advisory Committee meeting