Is Your Company at Risk for a Regulatory Crisis?
If any of these questions leave you feeling uncertain about your regulatory risk, we can help.
- Are you conducting independent internal audits?
- Are you developing corrective action plans and making improvements based on the internal audit findings?
- Have you conducted any recalls? If so, have you discussed these recalls with FDA?
- Do you have a recall contingency plan, and have you rehearsed it?
- Are you trending complaint, deviation, non-conforming material, etc. data?
- Are you reacting to these above trends?
- Do you often find yourself leveraging an atypical process (i.e. material review board, etc.) to release product? (indicates high levels or non-standard production deviations)
- Do you have product deviations that remain "open" for longer than 30 days?
- Has the review of your applications been delayed due to deficiency letters from the regulatory authorities?
- Are you monitoring your commitments to FDA to verify completeness?
- Are you aware of (and managing) all site, business unit or divisional communication with FDA?
- Do you understand how to integrate pharmacovigilance and technical product complaint data to meet FDA's current expectations? Do you know where those expectations are published?
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