Marketing Application Planning Tool

This tool has been designed to identify and collect the information necessary to begin planning your marketing application submission (NDA/BLA/MAA/NDS). If you’re looking to outsource the preparation and filing of your submission, your answers to these questions will give us a better understanding of your program and will help us provide an accurate cost estimate. Fill in as much information as possible; however, some questions might not be applicable for your submission, so leave those blank or enter “N/A.” If you have any questions, or if you’d like to speak to one of our regulatory submissions experts, please contact us at or 919-408-8000.