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GMP GXP Quality Audit Services:

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

  • ​​GMP/GLP/GCP GXP Audits - Drugs, Excipients & APIs
  • Medical Device - QMS/QSR Audits - ISO 13485:2016
  • Combination Devices, MDSAP Audits
  • Vendor - Supplier Audits, CMOs, CDMOs
  • Laboratory Audits - GLP/GCLP - Part 58/OECD GLP
  • 21 CFR Part 11 Systems & Software Compliance Audits
  • Dietary Supplements & Cosmetics Manufacturing
  • Company Acquisitions & Compliance Audits
  • Mock FDA, EU, NMPA & WHO Audits
  • Clinical Audits, CROs, GCLP, Investigator Sites
  • Retail Market Supplier GMP Certificates
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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!

Remediation:

  • Gap Analysis Support & Fillfulment Services​​
  • 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
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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!

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  • 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

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GMP, GLP, GCP and QMS Audit and Auditing Remediation
Remediation

 

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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

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

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Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

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

  • 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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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

483Help.com
Providing FDA Compliance Consulting, Design/Build, Engineering, Construction, Commissioning and Validation/Qualifications for the FDA / EMA Regulated Industry.

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