GxP Consultancy

GxP is a general term for Good x (anything) Practice quality guidelines and regulations.

Our expertise is in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice in the Quality Control laboratory.

There's much more to a Quality System than just auditing!
Quality Management System

GCP Consultancy

• Regulatory Inspection preparation and follow-up:

◦Assessment of inspection-readiness of paper TMF, e-TMF or hybrid TMF

◦Inspection training “mock inspection”

◦Review and handling of inspection response

• Definition and demonstration of sponsor oversight activities

• Definition and implementation of data management QMS


Training is provided in-house tailored to specific customer needs.

Some of our courses have been specifically for:

  • Good Clinical Practice: introductory, refresher, updates
  • Good Clinical Practice for Data Management
  • Good Clinical Practice for Medical devices
  • Good Clinical Practice for the Laboratory
  • GCP and GLP in the Laboratory
  • Good Manufacturing Practice for IMP
  • Good Manufacturing Practice for Clinical professionals

GxP SOP Systems

  • Diagnostic and Health check
  • Re-engineering

Your QMS and SOPs should serve the business; not the other way around.

"Thank you again. Your preparation helped us a lot!"

Mock Inspection and GCP Regulatory Inspection Preparation,

Executive Clinical Director