Regulatory & Quality
Your firm's Regulatory and Quality system forms the basis for all ongoing GxP work. Courant has years of experience providing service solutions for reviewing and improving these systems.
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We Can Design Quality Systems for:
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Production
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Facilities and Equipment
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Laboratory controls
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Materials
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Packaging
Within the Quality System, we can also provide the following services:
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Policies, Standards, SOP Preparation, and/or Optimization
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Batch Record Review
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Remediation Project Management
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Quality Systems Development, Assessment, Remediation
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Root Cause Investigations and Corrective Action/Preventive Action (CAPA) Remediation
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Third-party GMP and GLP Compliance Auditing
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Mock FDA/International Regulatory Agency Inspections & PAI Readiness
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Due Diligence Compliance Inspections, Audits and Assistance
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FDA Actions (483 Observations, Warning Letters, Consent Decrees) Remediation
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Data Integrity Compliance
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Mergers & Acquisitions (M&A) regulatory integration
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We’ve offered services in environments governed by GMP, GLP, GCP, and QSRs, and for the biotech, pharma, device, and diagnostic industries.