Phama Biotech Services
REMEDIATION OF ENFORCEMENT ACTIONS
QualiCulture supports the pharma biotech companies in responding to inspectional observations and enforcement actions. Our team includes experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, TGA, etc.). Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues. We can help companies in providing comprehensive and holistic responses which provide the necessary coverage to the applicable regulations, CAPA (issue-specific and global), and impact on the quality of the products in relation to FDA 483 Inspectional Observations, warning letters, critical findings from European authorities, and import alerts.
Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.
In order to accomplish this our experts develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.) such as FDA Form 483, Warning Letter, Critical EU Agency Findings, Data integrity, Import Alert, and more. We develop solutions collaboratively with companies to achieve a practically compliant quality system to prevent future occurrences of similar compliance deficiencies. It includes.
Evaluation of observationCorrection of the issue – Issue specific and Systemic / Global CorrectionsImpact AssessmentContainment Actions and Field action determinationImmediate and Interim actions to eliminate immediate potential riskExtension of the scope if applicable to other processes, products and sitesEffectiveness Check plan and ExecutionREGULATORY MEETING/INTERACTIONS:
We provide assistance to clients for meeting interactions with regulatory agencies. It includes
Evaluation of Remedial Actions and Preparing briefing documents (Presentations) Organizing meeting preparation sessions