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GXP Engaged Auditing Services

GXP Engaged is a leading QA auditing and consultancy company that provides global QM?QA support for all pharmaceutical, biotech and medical device companies as well as academia.

GXP Engaged has developed a reputation for delivering the highest quality services to clients. The team of over 300+ highly experienced, fully qualified auditors across 65+ countries is well-positioned to continue supporting clients with global QA services.

In 2024, GXP Engaged acquired Polaris Compliance Consultants, Inc. and expanded the presence and expertise to the US market.GXP Engaged’s acquisition of SwissPharmAudit GmbH, at the same time, accelerates global growth, increasing penetration and reach, particularly in Northern Europe and Switzerland, further establishing our position as the market leading provider of GxP quality assurance and consulting services.

Our services include: 

  • Quality Assurance auditing across all GxP areas, including:

o    GCP (Investigator Site Audits, Vendor Qualification Audits, Document Audits, TMF Audits, Internal System Audits etc.)
o    GLP (Facility Audits, Study-based Audits etc.)
o    GCLP
o    GMP/GDP
o    GVP
o    CSV
o    Medical Devices
o    Animal Health
o    ISOs (9001, 14155, 13485 etc.)

  • QA Consultancy
  • Inspection Preparation and Support
  • QMS Development and Optimization
  • SOP and Documentation writing
  • Due-diligence for GxP compliance

 

Availability for Work

Remote, Worldwide

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Laboratory Practice (GCLP), Good Distribution Practice (GDP), Pharmacovigilance (GPvP), Information Technology (IT), Medical Devices, Quality Management Systems (QMS), Quality Risk Management (QRM), Standard Operating Procedures (SOPs), Inspection Preparation

Contact Details

Sarah Welburn
GXP Engaged Auditing Services
Innovation House,
Innovation Way,
Discovery Park,
Sandwich,
Kent,
CT13 9FF
United Kingdom

+44 (0) 7709447253

 

E-mail: info@gxp-auditing.com

Website: https://www.gxp-auditing.com/ 

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