ENSURING DOMESTIC (FDA) AND INTERNATIONAL REGULATORY COMPLIANCE AND PEACE OF MIND FOR MORE THAN 22 YEARS
Services
BUILDING TRUSTED PARTNERSHIPS IN CLINICAL RESEARCH, GXP REGULATORY COMPLIANCE AUDITING AND CONSULTING SINCE 1994
Services
MORE THAN 400 CLIENTS CHOOSE CLINAUDITS LLC TO DELIVER BEST PRACTICES IN GCP, GMP, GLP, GDP, AND GTP COMPLIANCE AUDITS.
Services
Regulatory Compliance GXP Auditing and
Consulting Services Since 1994
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Good Clinical Practices (GCP)
ClinAudits employs a team of expert consultants for all types of regulatory compliance auditing projects. Our more than 50 auditors are regionally based throughout…
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Good Manufacturing Practices (GMP)
Experienced ClinAudits consultants thoroughly understand the drug development process so they can guide…
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Good Tissues Practices (GTP)
ClinAudits provides comprehensive and principled audits for Regulatory Agency Response Formulation and…
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Good Laboratory Practices (GLP)
As an independent, niche provider of auditing and consulting for GLP, our focus is on maintaining close communication with…
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Risk Evaluation & Mitigation Strategy (REMS)
ClinAudits assures navigation and guidance for compliance with the FDA Amendments Act of 2007 (FDAAA) requirements…
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Quality Risk Management
ClinAudits has can help clients with early development of risk management within their drug development processes…
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Animal Health
ClinAudits provides a full range of high-value animal health clinical Development and Consulting services…
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Tobacco
ClinAudits GXP pharmaceutical auditing expertise can now assist clients in tobacco manufacturing and retail…
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Remediation
An important part of conducting audits is the review of audit observations and Corrective Action and Preventive Actions (CAPA)
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Related Services
Including, but not limited to, clinical operations, project management, monitoring, data entry, data management, biostatistics, medical writing …
