When quality problems are widespread or recurring, remediation becomes unavoidable. Companies can face backlogs of open investigations, repeated inspection findings, regulator concern about data reliability, or even restrictions on manufacturing and clinical work. In these situations, the cost of delay is high, and leadership has to stabilize operations while rebuilding confidence with FDA and other authorities. Real remediation is more than patching observations. It requires a structured program that tackles root causes, redesigns weak processes, and coordinates changes across people, systems, and sites so the same issues do not return.
HIC leads remediation as an organized change effort rather than a series of isolated fixes. Experienced remediation leads work alongside your quality and operations teams to map the full problem, set up governance that tracks commitments and risks, and prioritize actions that protect patients and product supply. We help redesign processes for investigations, monitoring, data integrity, and vendor oversight so they are both compliant and workable in daily use. Independent effectiveness checks are conducted to provide objective evidence that new controls are functioning as intended, giving regulators a clear view of progress. The outcome is a program that supports a return to compliance and helps build a stronger, more resilient quality system.
Remediation that produces lasting control
- We bring senior remediation leaders who have guided organizations through high stakes FDA challenges and sustained oversight
- Our teams establish program governance and tracking so ownership, timelines, and risk are visible to leadership and regulators
- We redesign key quality and operational processes to address root causes while improving efficiency and clarity for staff
- Independent effectiveness verification gives regulators confidence that corrective actions are working and that issues are unlikely to resurface
