Our Services
Quality Assurance Expertise for Regulated Environments
QualiPath provides specialist support across quality assurance, professional development, and project delivery. We work with organisations and professionals who want stronger systems, clearer direction, and practical support that leads to real progress.
Qualipath provides advisory, documentation, quality systems, and readiness support. Sponsor, investigator, legal representative, ethics, regulatory, and formal trial management responsibilities remain with the appropriately appointed organisations or individuals unless separately agreed in a formal written arrangement.
Quality Assurance and Compliance
We support regulated organisations in strengthening compliance, improving operational quality, and maintaining inspection readiness across GCP, GMP, GDP, and GVP.
Quality Systems Development and Review:
We help organisations build, strengthen, and refine quality systems that support compliance, operational control, and continuous improvement.
Services include:
Audit, Inspection, and Certification Support:
We provide practical support to help organisations prepare for audits, inspections, and certification requirements with greater confidence and clarity.
Services include:
Specialist Regulatory and Operational Support:
Services include:
Clinical Trial Set-Up & GCP Support
QualiPath supports organisations preparing to set up or strengthen clinical trial processes in line with Good Clinical Practice expectations. We help clients bring structure, clarity, and control to trial documentation, responsibilities, training, essential records, and readiness activities. Clinical trial set-up can feel complex, especially for smaller organisations, new research sites, healthcare providers, or teams entering regulated research for the first time. QualiPath provides practical support that helps teams understand what needs to be in place, what needs to be documented, and how to approach trial readiness in a proportionate and organised way.
Services include:
- Clinical trial readiness review.
- GCP documentation support.
- Trial set-up checklist development.
- Trial Master File and Investigator Site File structure support.
- SOP creation and review for trial-related processes.
- Delegation log, training log, and responsibility matrix support.
- Vendor and service provider oversight documentation.
- Risk assessment and quality planning support.
- Audit and inspection readiness support for GCP activities.
- Support with corrective actions following clinical trial audits or findings.
- Practical guidance for teams new to clinical research.
Mentoring and Coaching for QA Professionals
We support quality professionals who want to strengthen their profile, grow in confidence, and move forward with purpose in their careers.
Services include:
- CV and online profile revamp
- Cover letter and personal statement preparation support
- Interview preparation
- Leadership and career progression mentoring and coaching
- Professional branding
Project Management Support
We provide structured project support to help teams plan effectively, stay organised, and deliver with greater clarity and accountability.
Services include:
- Project Management Office support
- Project initiation and planning support
- Project evaluation and reporting
