AUDITS:Performing audits is a skill nearly every consultant company can help you with. Where we are different is that we not only identify any cGMP issues but we also provide solid recommendations on the most effective way to resolve those issues.
Quality Systems: Has your Quality Department achieved a clear oversight of how your quality systems are operating. You would maybe be surprised to learn how many large companies are operating at a sub-optimal level. Some questions you maybe should be asking yourself: “Just how good is you good”?, “ How predictable is my manufacture and supply capability”?.
Interim Control: At times things do go wrong. Do you know how you can build effective interim controls that will help you maintain good standing with the FDA until you have fixed what went wrong? We can help you build these often necessary steps as you remediate your systems.
Backlog reduction: Unpredictability of supply always comes in tandem with every increasing backlogs in deviation investigations, CAPA implementations, batch record reviews and disposition etc. When these occur the most common action is to keep adding more resources to fix the problem. Problem is that this seldom eliminates a reoccurance of the problem. We know how it should be done. Let us help you.