Mock FDA - PAI - Suppliers

GMP - GCP - GLP - ISO

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HACCP / Food Audits
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             The Auditing Group

                           Auditing, Training and Remediation
CGMP, GCP, GLP, QMS, ISO, and Computerized Systems
with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.

  • GMP Audits - Bio-pharmaceuticals - Excipients and APIs

  • QMS/QSR Audits - Medical Device - ISO 13485 - EU 745/2017

  • Suppliers and Contractor Audits - CMOs, CDMOs, Labs.

  • GLP Audits - 21 CFR Parts 58, 210/211 and Clinical (GCLP)

  • 21 CFR Part 11 Electronic Systems & Software

  • Validation Audits - Process, Facilities, Equipment and Software

  • Food & Dietary Supplements

  • Company Acquisitions & Risk Assessments

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

  • Remediation and Validation and Gap Analysis

  • Quality Management System (QMS) Audits (GMP)

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

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Require a GMP, GLP or GCP Vendor/Supplier Audit?
Contact us for a turn-key 1, 2, or 3-day on-site Audit!

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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