QGENYX — Pharmaceutical Compliance, GMP Audits & Regulatory Consulting
Global GxP audits

Global GxP Audits.
Smarter Supplier
Qualification.

Trusted by Quality teams worldwide
Audits completed
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Qualified auditors
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Countries covered
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Customer satisfaction
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Audit types GMP Audits GCP Audits GLP Audits GDP Audits GVP Audits ISO Audits Auditee Management

Supplier qualification shouldn’t slow down your business.

Finding the right supplier is only the beginning. Qualifying sites, tracking CAPA commitments, re-auditing periodically and controlling cost all land on the same team. QGENYX makes this simpler.

  • Qualify new suppliers
  • Assess GMP/GxP compliance
  • Manage global supplier networks
  • Meet regulatory expectations
  • Review audit reports
  • Track CAPA commitments
  • Re-audit suppliers periodically
  • Manage increasing audit workloads
  • Control qualification costs and timelines

One partner. One coordinated process. Global audit capability.

Audit library

Don’t always start an audit from zero.

Access existing audit intelligence where available, participate in upcoming audits, or commission an audit specifically for your requirements.

01

Audit Report Database

Access available audit reports from previously assessed suppliers and manufacturing sites.

Save time. Reduce duplication. Accelerate supplier qualification.

02

Join an upcoming audit

Participate in audits already scheduled at a site you need qualified, and share the report.

Lower cost. Faster scheduling. No duplicated site visits.

03

Commission an audit

Request an audit designed specifically for your products, quality systems and audit scope.

Your scope. Your criteria. A report built for your dossier.

Request library access

Accessing an existing report

  1. 1. Browse or search the library and select the reports that interest you

  2. 2. Sign the sharing agreement — we handle every permission needed

  3. 3. Complete payment on a single, transparent fee

  4. 4. Report is issued to you, with updates released automatically

Supplier
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Reports are released under a sharing agreement. Site details and audit dates are shared on request.

Explore the full library
Services

One partner. One coordinated process.

Independent, reliable and cost-effective GxP solutions for pharmaceutical, biotech, medical device and healthcare companies worldwide.

  1. 01

    GxP Audits

    GMP, GCP, GLP, GDP, GVP and ISO audits, delivered by qualified auditors with the technical and regulatory expertise your scope demands.

  2. 02

    GxP Consultancy

    Practical support on quality systems, gap remediation, auditee management and inspection readiness across every GxP discipline.

  3. 03

    Regulatory Services

    Submissions, dossiers, CTD modules, pharmacovigilance documents and regulatory medical writing — set out in full below.

  4. 04

    Strategic Sourcing

    Identifying and evaluating suitable suppliers against your product requirements, market needs and applicable regulatory expectations.

Why Qgenyx

Why Quality teams choose Qgenyx

Eight reasons Quality and Procurement teams hand their supplier qualification programme to one partner.

01

Global Auditor Network

Qualified auditors across major pharmaceutical and regulated markets.

02

Deep GxP Expertise

Practical experience across GMP and other GxP disciplines.

03

Faster Scheduling

Flexible auditor deployment designed to support demanding qualification timelines.

04

Cost-Effective

Flexible audit models designed to reduce the total cost of supplier qualification.

05

Consistent Reporting

Clear, structured reports designed to support effective Quality decision-making.

06

End-to-End Support

From audit planning through CAPA follow-up and closure.

07

Independent

Objective third-party assessments without compromising audit integrity.

08

One Global Partner

Coordinate audits across India, China, Europe, USA and other markets through one partner.

Auditee management

Reduce your audit burden with Qgenyx

Coordinating auditors, hosting audits, reviewing reports, managing CAPAs and following up on closures places a significant burden on Quality and Procurement teams.

One audit. One comprehensive report. Less internal effort.

Our experienced auditors conduct GxP supplier audits tailored to your requirements, with the relevant products and quality systems in scope. From planning and execution to report finalisation, CAPA follow-up and closure, Qgenyx manages the process with a clear, structured methodology.

Take the audit burden off your team

Reduce the burden of managing multiple CAPAs

CAPAs from multiple customers and individual audits consume significant internal resources. A structured audit and CAPA process gives you:

  • Independent and objective third-party audits
  • Comprehensive, client-specific audit reports
  • Significant savings in internal time and resources

Reduce audits. Reduce CAPA workload. Reduce internal resources.

Spend less time coordinating audits and more time on critical quality priorities.

Regulatory medical writing

Science-driven documentation for global compliance

High-quality, compliant and impactful scientific documentation supporting your product journey from development to global approval.

01

Clinical development documentation

  • Investigator Brochures (IB) & updates
  • Clinical study protocols & amendments
  • Informed Consent Forms (ICF) & patient diaries
  • Clinical Study Reports (CSR)
  • Patient safety narratives
02

CTD modules & submission documents

  • Module 2.4 & 2.6 — nonclinical overview & summaries
  • Module 2.5 & 2.7 — clinical overview & summaries
  • Integrated Summary of Safety (ISS) & Efficacy (ISE)
  • Module 4 & Module 5 compilation
  • IND, NDA, generic, hybrid & MAA submissions
03

Pharmacovigilance documents

  • PSUR, PBRER & PADER
  • Risk Management Plans (RMP)
  • Development Safety Update Reports (DSUR)
  • Addenda to clinical overviews
04

Regulatory, product & scientific documents

  • SmPC, PIL, product monographs & pack inserts
  • Health authority responses & briefing documents
  • Scientific justifications & medical rationales
  • Biowaivers
05

Specialized toxicological documents

  • Permitted Daily Exposure (PDE) reports
  • Occupational Exposure Limit (OEL) reports
  • Environmental Risk Assessments (ERA)
06

Regulatory authority communications

  • Regulatory authority response documents
  • Literature-based documentation
07

Submission & quality support

  • Strategic submission planning & authoring
  • In-depth dossier gap analysis
  • Quality control (QC) of regulatory documents
  • Submission-readiness assessments
How we work

Your extended Quality team.

Qgenyx works as an extension of your Quality organization — helping you plan, coordinate and execute supplier audits without adding unnecessary internal workload.

Qgenyx works as an extension of your Quality organization — helping you plan, coordinate and execute supplier audits without adding unnecessary internal workload.

STEP 01

Plan

Define scope, requirements, audit criteria and timelines.

STEP 02

Qualify

Identify and assess manufacturing sites and suppliers.

STEP 03

Audit

Deploy qualified auditors with relevant technical and regulatory expertise.

STEP 04

Report

Receive structured, detailed audit reports with clear observations.

STEP 05

CAPA

Support CAPA review, follow-up and closure.

STEP 06

Maintain

Support ongoing supplier qualification and periodic reassessment.

About Qgenyx

Experience that makes the difference

Our management team brings more than 50 years of experience in the pharmaceutical industry, deep knowledge and networks in the third-party audit industry, and a thorough understanding of the pharmaceutical quality and compliance landscape.

This industry experience enables Qgenyx to provide a practical, efficient and reliable audit solution that goes beyond simply conducting an audit.

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Years of combined pharmaceutical experience
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Qualified auditors in our global network
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Countries covered by our audit programmes

Led by third-party audit specialists

Qgenyx is led by professionals with extensive experience in third-party GxP auditing, supplier qualification, pharmaceutical quality systems and global audit management. That experience lets us anticipate challenges, select the right auditors and manage audits efficiently — while maintaining the quality and integrity pharmaceutical companies expect.

More than an audit provider

Qgenyx is not an auditor marketplace or a loose network of independents. Our management team knows what pharmaceutical companies expect from a professional third-party audit partner — because it has managed those audits and worked across the pharmaceutical supply chain.

We combine that industry knowledge with a global network of qualified auditors to deliver consistent, independent and client-focused audit solutions.

Countries served

One Audit Partner. Multiple Markets.

Whether you are qualifying an API manufacturer in India, a CDMO in Europe, a supplier in China or a manufacturing partner in the USA, QGENYX provides a coordinated approach to global supplier auditing.

Countries served European Union — strong presence, country by country
  • India
  • China
  • USA
  • Canada
  • Brazil
  • Mexico
  • South America
  • MENA region
  • Lebanon
  • Australia
  • Hong Kong
  • Indonesia
  • Ukraine
  • Russia
  • United Kingdom
  • France
  • Poland
  • Hungary
  • Greece
Industries

Supporting quality across the life sciences

Pharmaceutical

API • Finished Products • Intermediates • KSM • Excipients

Biotechnology

Biologics • Biotechnology Manufacturing • Service Providers

Medical Devices

Manufacturing • Suppliers • Quality Systems

Clinical Research

CROs • Clinical Sites • Service Providers

Healthcare & Life Sciences

Critical suppliers and regulated service providers

Resources

Case studies

How Qgenyx helped clients solve real audit challenges.

Case study 01

Faster audit scheduling with local expertise

Challenge

A pharmaceutical company needed to complete a supplier GMP audit within a tight timeline. Coordinating a qualified auditor with the required technical expertise and local availability was proving challenging.

Qgenyx solution

Qgenyx quickly identified and deployed a highly qualified local auditor with relevant GMP experience and knowledge of the applicable regulatory requirements. Our local auditor network let us coordinate the audit efficiently and secure a suitable date far faster than conventional arrangements.

Outcome

The audit was scheduled within a significantly shorter timeframe, helping the customer accelerate supplier qualification, reduce coordination time and maintain their project timeline.

Key benefit Faster scheduling Qualified local expertise Reduced coordination effort On-time supplier qualification

Let QGENYX take the audit burden off your team

Reduce audits. Reduce CAPA workload. Reduce internal resources. A senior consultant replies within one business day.

QGENYX

Pharmaceutical compliance, GMP audits and regulatory consulting for global manufacturers.

CERTIFIED COMPANY ISO 9001:2015
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