Quality Assurance

Quality Assurance Auditing
Our TMC Auditors are experienced in good clinical practice (GCP) and good manufacturing practice (GMP) audits and can cover investigational sites, clinical trial supplies, manufacturing sites and clinical research organisations (CROs).

Expert Quality Assurance Consultancy
We can provide support, advice and training across multiple GxP areas (e.g. GCP, GPvP, GMP, CSV/IT, GLP), pre- and post marketing and ad hoc support for quality questions.

Embedded QA support
Provision of a dedicated QA professional for short or long-term projects, for a specific number of days/hours a week, to support the development of our client’s quality function (e.g. during peaks of activity, company growth or periods when a permanent headcount is not in post).

Quality Management System
Gap analysis and development of GxP compliant QMS.

Regulatory Inspection Preparation and Support

• Mock Inspections of Site, Study, CRO or Sponsor
• Inspection Readiness Training: Site/Sponsor/CRO staff
• MHRA Inspection Dossier Review
• Interview practise

Audits Services
We offer a comprehensive range of audits services, from one-off activities, to a seamless extension of the client’s global or European audit programme. This can include:

• Routine/For Cause Vendor/Supplier/CRO
• Investigative Site
• TMF
• Study
• Database/ePRO
• Process/System
• Audits
• IT/Computer system (e.g. QMS, TMF) validation
• CSR
• Lab

IT
Gap Analysis and Review of CSV validation documentation. QAsupport of validation projects.