Regulatory Strategy and Program Design

Our experienced consultants will work with you to outline a regulatory strategy and development program for your product.  This includes reviewing any FDA communications and planning for upcoming meetings and Advisory Committees.  The goals of the program will be met through iterative programs to evaluate label comprehension, self-selection and actual use studies.  Some programs require additional clinical studies to be conducted; we can design and conduct your clinical trials too.

Strategy Sessions are planned and often conducted at our Concentrics Strategy Center in Parsippany, NJ.