Our Services

GxP Auditing

Through initial engagement, collaboration and subsequent audit activity, Scorpius Quality Consulting will determine whether clients, their investigator sites and/or contracted vendors (as applicable) have the facilities, equipment, personnel, experience and procedures in place to complete their respective duties and functions to appropriate regulations, standards and guidelines. From one-off audit events to full set up, management and execution of internal and external audit programmes, Scorpius Quality Consultancy can assist with all your GxP audit needs.

Vendor Management

Scorpius Quality Consulting can take the strain of onboarding and managing your vendors, from initial due diligence assessment through quality approval and subsequent oversight and re-qualification activities.

Quality Management Consultancy

Contact Scorpius Quality Consulting to see how we can assist with gap assessments, policy and standard operating procedure (SOP) development, Quality Person (QP) support, mock inspections and other Quality Assurance support.

Good Distribution Practice (GDP)

• Clinical Trial Supply/Investigational Product

• Depots (Warehouse, Storage and Distribution)

Good Manufacturing Practice (GMP)*:

• Contract Development and Manufacturing Organisations (CDMOs)

• Drug Product, Drug Substance, Active Pharmaceutical Ingredients, Excipients

• Combination Products

• Cell-Bank Storage and Management

• Laboratories (Analytical, Microbial, Stability Testing)

• Packaging and Labelling Operations

*GMP audits are provided by a trusted consultancy partner. Referrals can be provided on request.

Good Clinical Practice (GCP)

• Pharmacies

• Phase 1 Units

• Clinical Investigator Sites (routine, targeted, for-cause)

• Home Health Services

• Biological Sample Logistics

• Study Protocol, In-Study, Data and Report Audits

• Trial Master Files

• Archive Facilities

Good Laboratory Practice (GLP):

• Non-clinical Contract Research Organisations (CROs)

• Vendor, Facility, Study Plan, In-Study, Data and Report Audits

Vendor Management

• Risk Assessments

• Vendor Questionnaires

• Qualification, Requalification, In-Study, For-Cause Audits

• Vendor Lists/Databases

• Quality Agreements

• Vendor Oversight

Good Clinical Laboratory Practice (GCLP):

• Central (Safety) Laboratories

• Speciality/Diagnostic Laboratories (e.g., Genotyping, Biomarker Assays, Bioanalytical)

• Imaging laboratories

General Quality Management Consultancy

• Risk Assessments

• Vendor Questionnaires

• Qualification, Requalification, In-Study, For-Cause Audits

• Vendor Lists/Databases

• Quality Agreements

• Vendor Oversight