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GMP GXP Quality Audit Services:

FDA, EU, ISO, Vendors & Supplier GMP QMS Audits, Gap Analysis, Training & Remediation Services

  • ​​GMP Audits - Drugs, APIs, Excipients & DEA
  • Medical Device - QMS/QSR Audits - Part 820 QSR / ISO 13485
  • Vendor - Supplier Audits, CMOs, CDMOs, CAO, CRO, CPO
  • Dietary Supplements
  • Laboratory Audits - GLP/GCLP - Part 58/OECD
  • 21 CFR Part 11 Systems & Software Compliance Audits
  • Cosmetics & Healthcare Product Manufacturing
  • Company Acquisitions & Compliance Audits
  • Mock FDA, EU, NMPA & WHO Audits
  • Clinical Audits, CROs, GCLP, Investigator Sites
  • Retail Market Supplier GMP Certificates
  • Combination Devices, MDSAP Audits, 21 CFR Part 4 Support

Remediation & Gap Analysis:

  • 483 Help!  EIR 483 and Warning Letters - Compliance
  • Gap Analysis Support & Turn-Key GMP / Turn-Key GMP​​
  • Standard Operating Procedure Turn-key Development
  • Validation Audits / Writing - Process & Equipment
  • Remediation, Validation & Gap Analysis Report
  • As-Built Drawing Qualifications & Validation
  • Engineering GMP Evaluation & Analysis Services
  • DEA Controls - Facility Qualifications
  • Facility & Site Qualification Services - BOD Development
GMP, GLP, GCP and QMS Audit and Auditing Remediation
Retail Good Manufacturing Practice GMP Certificate Program
Supplier GMP Certificate Program for the Retail Market
  • Dietary Supplements & Vitamins

  • Cosmetics & Topicals

  • Protein & Nutrient Bars and Drinks

GMP Certificates supporting your Product Quality & GMP Compliance!

List of Common Procedures 

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!

  • GMP Audits - API/Excipients

  • GLP Audits - QC, Testing and LIMs, 

  • Mock FDA/EMA, PAI, Pre-ISO

  • Vendors, Suppliers and Contractors

  • Pharmaceuticals / Supplements

  • Medical Devices / IVDs

  • Cosmetics

  • Biologics, Blood, Cell, Tissue

  • Validation Audits

  • Engineering Audits

  • Document Audits

  • Clinical Audits

  • Investigator Sites

  • Clinical Data Management

  • Clinical Electronic Systems

GMP, GLP, GCP and QMS Audit and Auditing 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.

  • Project Management

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

GMP Engineering, GMP, GLP, GCP and QMS Audit and Auditing Remediation
CAPA Manager, Remediation and GMP Audit, Auditing and Remediation



                            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.

  • Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training

  • 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.

GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
Mock FDA - PAI - Supplier Audits
Food and Drug Assistance, Food and Drug Association, FDA
Retail Good Manufacturing Practice GMP Certificate Program
GMP, GLP, GCP and QMS Audit and Auditing Remediation
GMP Boot Camps GMP, QMS , FDA Training
GMP, GLP, GCP and QMS Audit and Auditing Remediation
Providing FDA Compliance Consulting, Design/Build, Engineering, Construction, Commissioning and Validation/Qualifications for the FDA / EMA Regulated Industry.

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