Bringing Your Program Through the FDA Approval Process
GZP focuses individually and intensively on each client program to offer the best strategic advice for facilitated medical product progress. Instead of simply quoting FDA guidelines, GZP gathers a comprehensive understanding of all client data available, combines this with global expertise, and makes specific suggestions based on the entire package. The regulatory environment is always changing, new technologies are being developed and the FDA is constantly refining what it requires of Sponsors. Each key question may have a number of “correct answers,” and GZP, to provide the best advice for a particular program, understands that individual data points, studies and supporting documentation, channeled in a logical and targeted manner, can lead to a “yes” answer from the Agency. This understanding is critical to successful negotiations via the regulatory process. With this approach, GZP provides specific strategic advice on a project, always focused on helping clients achieve the next milestone, with consideration of the ultimate milestone – product approval.