Home Company Services Testimonials News Contact Internal/External QA Resources and Consultancy MAINTAINING COMPLIANCE IN A COMPLEX REGULATORY LANDSCAPE With our global network of quality professionals, we have the experience and expertise to offer you consultancy and support quickly and flexibly. Whether you have one specific ad-hoc question or you need full-time, in-house QA support, we have the resources you need to navigate the complexities of the ever-changing regulatory landscape. We offer the following services either on an ad-hoc, limited contract or fully insourced basis: Inspection support Inspection readiness assessments Inspection preparation (of sites, vendors or sponsor) Mock inspections On-site inspection support Post-inspection follow-up support QA Services Set-up, evaluation or optimisation of CAPA systems Surveillance of CAPAs Definition of quality metrics Issue tracking Study- or programme-specific quality plans Training Case Histories - Internal/External QA Resources and Consultancy Inspection Support Regulatory Agency Support +49 89 93 00 38 98 info@gxp-auditing.com Legal notice Privacy policy If you agree, we use cookies to integrate external services and media. Further information can be found in our data protection policy. Please select what kind of cookies should be allowed to be set by confirming with "Accept selected" or accept all cookies by confirming with "Accept all": Functional External media (YouTube, Vimeo) Accept selected Accept all imprint

Home Company Services Testimonials News Contact 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. We warmly welcome feedback, additions, updates, suggestions for improvement in our review/interpretation. GXP Engaged would like to add the disclaimer that the information on the spreadsheet is provided according to our review and interpretation of the guidance documents. Some documents do not give clear guidance and some text is open to interpretation. We discourage the taking of any specific action solely on the basis of the results presented. The original guidance document should always be consulted, or clarification sought from the relevant authority. GXP-Engaged_COVID19_Regulatory_Guidance_Assessment_with_Change_Log_status_20210901.xlsx XLSX file , 72 KB Back +49 89 93 00 38 98 info@gxp-auditing.com Legal notice Privacy policy If you agree, we use cookies to integrate external services and media. Further information can be found in our data protection policy. Please select what kind of cookies should be allowed to be set by confirming with "Accept selected" or accept all cookies by confirming with "Accept all": Functional External media (YouTube, Vimeo) Accept selected Accept all imprint