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
The Auditing Group
A division of
The GMP Quality Groups
GMP GXP Quality Audit Services:
FDA, EU, ISO, Vendors & Supplier GMP QMS Audits, Gap Analysis, Training & Remediation Services
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GMP Audits - Drugs, APIs, Excipients & DEA
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Medical Device - QMS/QSR Audits - Part 820 QSR / ISO 13485
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Vendor - Supplier Audits, CMOs, CDMOs, CAO, CRO, CPO
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Dietary Supplements & Food GMP Certificate Programs
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Laboratory Audits - GLP/GCLP - Part 58/OECD
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21 CFR Part 11 Systems & Software Compliance Audits
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Cosmetics & Healthcare Product Manufacturing
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Company Acquisitions & Compliance Audits
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Mock FDA, EU, NMPA & WHO Audits
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Clinical Audits, CROs, GCLP, Investigator Sites
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Retail Market Supplier GMP Certificates
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Combination Devices, MDSAP Audits, 21 CFR Part 4 Support
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Validation Audits - Process, Equipment, 21 CFR Part 11.10(a), Facilities
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
Join The Quality Groups & Expand Your Exposure!
Business Development Partners Wanted - Join our Team.
GxP Audits
All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!
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GMP Audits - API/Excipients
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GLP Audits - QC, Testing and LIMs,
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Mock FDA/EMA, PAI, Pre-ISO
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Vendors, Suppliers and Contractors
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Pharmaceuticals / Supplements
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Medical Devices / IVDs
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Cosmetics
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Biologics, Blood, Cell, Tissue
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Validation Audits
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Engineering Audits
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Document Audits
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Clinical Audits
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Investigator Sites
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Clinical Data Management
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Clinical Electronic Systems
Remediation
The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.
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Project Management
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CAPA Management
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Procedure Development
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Protocol Development
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Design / Build Engineering Analysis
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As-Built Qualifications
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Commissioning and Qualifications
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Validation Services
Turn-key or Hourly SME Quotes!
Gantt Driven Project Management
Training
The Auditing Group has teamed up with GMP Boot Camps to provide on-site or Virtual training for your Employees to satisfy your GxP requirements.
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Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training
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Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.