The Gap Analysis is an objective evaluation of a product in the context of a company’s stated goal (e.g., NDA submission). It is a strategic evaluation from a development, medical, regulatory, and commercial perspective. Gaps are identified and potential risk mitigation is provided. Timelines and estimated costs toward the stated goal are included.
Facet Life Sciences has conducted numerous program reviews and gap analyses. For each of these programs, we have identified risks and worked with clients to develop timely and cost-effective ways to mitigate those risks. Based on our experience with regulated product development and direct interactions with FDA, we have also provided peace-of-mind by reviewing and confirming solid development plans. We can objectively identify where you are in the product development lifecycle and provide an accurate timeline and cost estimate to get you to your stated corporate goal.