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.
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
We’ve offered services in environments governed by GMP, GLP, GCP, and QSRs, and for the biotech, pharma, device, and diagnostic industries.