Pre-submission meetings with the FDA can ensure that new product development efforts result in a satisfactory submission. Meeting with the FDA requires careful preparation and being unprepared can be disastrous. They are time-consuming and involve preparation for a successful outcome.

Paladin Medical will:

 Help you decide if a meeting is warranted
 Prepare you and your team
 Make all the arrangements
 Contact the right people at FDA
 Organize and plan your contact with FDA to give the best regulatory position possible
 Develop your proposal using a proven format
 Set an agenda for your face-to-face or teleconference meeting with key FDA personnel
 Help you express your company’s professional position and sound technical judgment