GXP
11.4.2022 10:54:05 CEST | Business Wire | Press release
As well as extending the reach of our comprehensive contract quality management and auditing services for our clients in the pharmaceutical, biotechnology, medical devices, nutrition and healthcare industries and also for regulatory authorities and academia, we intend to consolidate and expand our UK auditor directory with experienced auditors in all the GxPs and CSV, as well as to offer further development training to those auditors building up their portfolios. We believe this will particularly aid our UK, USA and APAC sponsors. Our UK office will be a base for both in-house and contract auditors, similarly to our operations in Munich HQ (2011) and in Vienna (2021).
Dr. Barbara Heumann, owner of the GXP Engaged group of companies, spoke today at the office opening in London, about her delight at extending the group’s services: “We provide our clients with the support needed to give them efficient oversight of their development activities from pre-clinical to post-marketing, from ad-hoc consultancy to set-up of complete QM systems, from single audits to full management and execution of annual audit programmes, from ad-hoc consultancy to complete inspection readiness programmes – our services can be provided flexibly, efficiently and quickly to the extent needed.”
UK company director, Jakki Welburn, continued: “We look forward to extending our UK QM professionals database, currently consisting of 17 highly experienced contract auditors. Our company success lies in the quality and experience of our QM professionals, most of whom we have worked with for many years and we already have a company-wide, stringent, qualification and onboarding process to build on, allowing us to carefully select our staff with documented tools and processes to ensure high standards.”
Summing up, Barbara concluded: ”Our clients choose GXP Engaged Auditing Services for our personal touch and global reach. We have over 90 QM professionals in over 60 countries and our tailored QM approach gives our sponsors the support they need in the regulatory area. Our new UK office will certainly foster this exceptional sponsor relationship.”
For more information, please see www.GXP-Auditing.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20220411005349/en/
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