--- title: GxP Auditing Services | Quality Confidential description: Mock regulatory, supplier, internal, and laboratory audits from a bench of 75+ senior auditors, including former FDA investigators and EU/UK Qualified Persons. --- [Skip to content](https://www.qualityconfidential.com/gxp-auditing#main-content) [![Quality Confidential Inc\_Final\_update 5.11.26 (1)](https://www.qualityconfidential.com/hs-fs/hubfs/Quality%20Confidential%20Inc_Final_update%205.11.26%20(1).png?width=315&height=135&name=Quality%20Confidential%20Inc_Final_update%205.11.26%20(1).png)](https://www.qualityconfidential.com?hsLang=en) - Services - [GxP Auditing](https://www.qualityconfidential.com/gxp-auditing) - [GxP Training](https://www.qualityconfidential.com/gxp-training) - [QMS Consulting](https://www.qualityconfidential.com/qms-consulting) - [Regulatory Support](https://www.qualityconfidential.com/regulatory-support) - [Document Preparation](https://www.qualityconfidential.com/record-review) - [Staff Augmentation](https://www.qualityconfidential.com/staff-augmentation) - [About](https://www.qualityconfidential.com/about-us) - [Contact](https://www.qualityconfidential.com/contact-us) # GxP Auditing Global GxP audit services for pharmaceutical, biopharmaceutical, and medical device companies When your organization is facing an inspection, a 483, or a supplier you cannot verify, you need more than credentials. You need a partner who protects your reputation as carefully as you protect patients. Quality Confidential is a women-owned GxP consulting firm providing customized audit services to pharmaceutical, biopharmaceutical, medical device, gene therapy, IVD, and cosmetic companies worldwide. Our rigorously vetted bench of 75+ senior auditors, drawn from a global network of 200+ senior to executive-level QA, QC, and RA consultants, has completed more than 1,500 audits across North America, Europe, Asia, the Middle East, and South America. Our auditors range from former FDA and regulatory authority investigators to certified lead auditors, EU/UK Qualified Persons (QPs), and specialized subject matter experts, each selected for technical depth, regional expertise, and cultural fit. 200+ Senior to executive-level consultants worldwide 75+ Senior auditors on the audit bench 1,500+ Audits completed across five global regions Our mission: help clients achieve sustainable, inspection-ready compliance, without compromising integrity or confidentiality. Authentic Communication · Work Ethic · Service Excellence · Integrity Above Profit · Partnerships from the Heart ## Audit Services ### Regulatory Mock and Preparation Audits Risk-based mock audits against domestic and international regulations. Employee coaching, documentation readiness (War Room 5S), and on-site support during hosted PAI, regulatory, and notified body visits. Mock audits increase readiness by identifying the topics that will be most scrutinized, establishing smooth processes for documentation retrieval and reconciliation, coaching employees on what to expect from investigators, and surfacing compliance issues early so remediation can happen before the visit. Our auditors can also be on-site during hosted audits to assist with presentation preparation, pre-entry document review, and request interpretation. ### Supplier Qualification and For-Cause Audits Individual audits and full supplier audit program management. Desktop and on-site audits, Approved Supplier List support, and Supplier Quality Agreement development for all GxP audits including but not limited to QMS, CMO, CRO, Clinical Sites. A robust supplier program confirms that a supplier can deliver on time, to specification, and in line with regulatory expectations for your markets. When something goes wrong at a supplier site, our auditors provide objective oversight of the investigation and deliver practical, unbiased recommendations for resolution. ### Internal Audit Programs Independent, qualified auditors who solve the two most common internal audit challenges: ensuring true independence and accessing specialized SMEs. Full-cycle program management from development through follow-up. Our team manages every aspect of the internal audit program, including program development or remediation, audit metrics that support company objectives, annual schedule development and tracking, and audit planning, execution, report writing, and follow-up. ### Laboratory Audits Independent audits of analytical, QC, and clinical (CLIA) laboratories against GMP, GLP, and GCLP requirements. Desktop and on-site assessments covering equipment qualification, method validation, sample and data management, and laboratory data integrity (ALCOA+). ## Global Reach ### Global Coverage Audits completed across North America, EU, Asia, Middle East, and South America. ### EU/UK Qualified Persons Auditors who are former regulators, plus EU/UK Qualified Persons (QPs), available to support European batch certification and QP-standard audits. ### Regional Sourcing Auditors sourced regionally to minimize client travel costs and ensure cultural fit and regulatory alignment. ### Multi-Language Capability Including dedicated Japanese/English conference interpreters for FDA and PMDA audit support. ### Regulatory Experience Experience across domestic and international regulations and standards, including but not limited to FDA, EMA, PMDA, TGA, and Notified Body audits. ## How We Qualify and Vet Auditors Auditors are chosen for each engagement based on education, certification, industry experience, knowledge of applicable regulations, regional and cultural considerations, and language requirements. Levels range from Senior Compliance Consultants for routine audits to Principal Consultants and former regulatory authority auditors for mock regulatory, pre-PAI, and remediation efforts. ### Former FDA Investigators Former FDA and regulatory authority investigators. ### Certified Lead Auditors ASQ CQA and ISO 13485 certified lead auditors. ### GxP Subject Matter Experts Specialized subject matter experts across GxP disciplines. ### Former Senior Executives Former senior industry executives. ### EU/UK Qualified Persons EU/UK Qualified Persons (QPs) for European batch certification and QP-standard audits. ## How We Stay Current on Regulations Regulations change constantly. We track those changes centrally so our auditors are always working from the current version. 1Regulatory Monitoring 2Controlled Library 3Tracked to Project 4Verified at Audit ## How an Audit Runs 1Preparation 2On-site 3Report 4Response 5Close-out ### Response Prepared by the auditor or by your team, whichever your process requires. ### Observation Criticality Criticality is classified against your quality system's definitions. Where you prefer, Quality Confidential provides reporting templates with established criticality definitions, alongside a full set of audit output templates. ### Execution Audit deliverables are executed through a 21 CFR Part 11 compliant DocuSign account, available for your use on any engagement. **WBENC Certified**Women-OwnedCertified Diverse Supplier ## Women-Owned Business Quality Confidential auditors bring decades of industry and FDA-facing pharmaceutical and biopharmaceutical experience. The Quality Confidential auditor network reflects the diversity of the global life sciences industry, with professionals spanning pharma, biotech, gene therapy, medical devices, IVD, and diagnostics across multiple countries. ## Why Quality Confidential ### Confidential by design No client logos, no case studies. Every engagement is a protected relationship. ### Senior-level expertise Every engagement is led by senior professionals with decades of real-world industry and regulatory experience. ### Integrity above profit We recommend only what serves patients and your long-term compliance. ### Regional sourcing Local and regional auditors minimize travel costs and ensure regulatory and cultural alignment. ## Facing an inspection, a supplier question, or an internal audit gap? Tell us what you are working through and we will match you with the right auditor, in complete confidence. 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