News

Supporting You with the Challenges You Face

The GXP Engaged Auditing Services group of companies announces the opening of its UK subsidiary, GXP Engaged Auditing Services UK Ltd.

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 our Munich HQ (2011) and in Vienna (2021).

Read more

COVID-19 | Regulatory Guidelines Review

Global Health Authorities have introduced guidelines for clinical trials due to COVID-19. GXP Engaged invite you to access our review of approx. 60 of these guidelines covering aspects affected by the pandemic such as the provision of IMP/Supplies to subjects, Subject Visits, Informed Consent, Monitoring & Remote SDV, Sponsor Risk Assessments, Protocol Deviations & Amendments, Safety Reporting etc.

Read more

SALSA! Make your audit Smarter

SALSA, Statistical Assessment Layer for Site Audits, is a statistical tool developed to facilitate the selection of study sites, data points and subjects for investigator site audits both remote or on-site.

Read more

The Engaged Database GmbH opens new, independent sister company in Vienna, Austria

In early July, The Engaged Database GmbH, with HQ in Munich, Germany, opened a new, independent sister company in Vienna, Austria.

Read more

Covid-19 | Remote Audit Concepts

The thoughts of the staff at GXP Engaged are with all those affected by COVID-19, the patients and their families, nurses, doctors and all those on the frontline helping to take care of the sick. We also understand what a difficult time this is for our customers trying to ensure the safety of subjects, preserve the integrity of their studies and working their way through the various guidance documents being issued by regulatory bodies.

Read more

Loading this resource will connect to external servers which use cookies and other tracking technologies to personalize and improve experience. Further information can be found in our privacy policy.

Allow external media