We consider quality to be the cornerstone of everything that we do and achieve for our clients.

Our dedicated team of world-class quality assurance experts (which include a number of ex-MHRA Inspectors) are available to support every aspect of a GxP Quality Assurance Programme.

We offer a wide range of flexible, scalable quality assurance services, from one-off audits, or quality questions, to providing comprehensive support, effectively acting as an integrated extension of our client’s Quality Function.

  • 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.

Get In Touch

Our team is ready and willing to support your quality assurance needs.

To discuss your specific project requirements, contact us today.