483 and Warning Letters
Your a large company with many years of experience with the FDA, you may be able to identify the problems and know what you need to do to fix them. But you may not have enough available staff to perform the extra work. If you are a smaller company that has not had a lot of experience in remediating 483s or Warning Letters, you may struggle with even identifying what you need to do to address the issues found by the FDA. You may also need advice about how to communicate with the FDA as you work through the issues.
We believe it is important to take a deliberate, educated, organized approach to addressing the issues identified in a 483 or Warning Letter. We have proven that Globiox’s project managers and subject matter experts are able to analyze the issues, determine solutions, develop a project plan with tasks, resources and a timeline, and develop a strategy for communicating progress to the FDA. Our team will give you the expertise, confidence, and perhaps culture change, needed to resolve your issues and put you back into compliance with regulations.