The Auditing Group
GMP - GCP - FDA, EMA, ISO & Vendor Audit & Remediation
U.S. Headquarters - In-Country China, India & South America GMP/GLP/GCP Auditors for Suppliers, CMOs and 'For-Cause' Audits!
01-856-437-5880
1, 2, or 3 day Onsite Turnkey Audits starting at $5,995!
GMP Audit & Gap Analysis Assessments
FDA, EU, ISO, Vendors & Supplier GMP QMS Audits, Full Gap Analysis, Training & Remediation Services
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GMP Audits - Drugs, APIs, Excipients & DEA
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Combination Device - Part 820 QSR / 21 CFR Part 211
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Vendor - Supplier Audits, CMOs, CDMOs, CRO, CPO
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Laboratory Audits - GLP/GCLP - Part 58/OECD
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Company Acquisitions & Compliance Audits
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Mock FDA, EU, NMPA & WHO Audits
Mock FDA - PAI - Supplier Audits
Remediation & Gap Analysis:
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483 Help! EIR 483 and Warning Letters - Compliance
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Gap Analysis Support & Turn-Key GMP / Turn-Key GMP
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503b Outsourced GMP Facility Qualifications
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Standard Operating Procedure Turn-key Development
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Validation Audits / Writing - Process & Equipment
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Remediation, Validation & Gap Analysis Report
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As-Built Drawing Qualifications & Validation
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Engineering GMP Evaluation & Analysis Services
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DEA Controls - Facility Qualifications
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Facility & Site Qualification Services - BOD Development
GMP Audits the Regulations
GMP Knows the Regulations!
