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The Auditing Group

  • GMP Audits - Excipients & APIs

  • Medical Device - QMS/QSR Audits

  • Vendor - Supplier Audits, CMOs, CDMOs

  • Laboratory Audits

  • 21 CFR Part 11 Systems & Software

  • Validation Audits - Process & Equipment

  • Dietary Supplements

  • Cosmetics

  • Company Acquisitions

  • Mock FDA, PAI, EU, MNPA & WHO Audits

  • Remediation, Validation & Gap Analysis

  • Clinical Audits, CROs, DMS, eDC, GCLP, Investigator Sites

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Mock FDA - PAI - Suppliers

GMP - GCP - GLP - ISO

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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

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

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.

  • 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.

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Mock FDA - PAI - Supplier Audits
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Providing FDA Compliance Consulting, Design/Build, Engineering, Construction, Commissioning and Validation/Qualifications for the FDA / EMA Regulated Industry.

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