Quality-system review
Assess the strength, clarity and effectiveness of processes and evidence across your QMS.
Consultancy
Practical pharmaceutical quality consultancy that creates progress.
Focused support to improve QMS performance, documentation, compliance confidence and inspection readiness.
Built around your operating reality
Clear priorities. Practical recommendations. Lasting improvement.
Setax reviews the issue, identifies the highest-value actions and supports your team with recommendations that can be implemented in the real world.
- QMS and process reviews
- GDP/GxP compliance support
- Good Clinical Practice (GCP) compliance and quality-system support
- SOP and controlled-document improvement
- Deviation and CAPA workflow support
- Audit and inspection-readiness preparation
- Responsible AI adoption within quality workflows
Consultancy services
Support where it will make the greatest difference.
Good Clinical Practice consultancy
Review GCP processes, clinical documentation, oversight, risk management, participant-safety controls and inspection readiness against current expectations.
Documentation improvement
Make controlled documents, SOPs, deviations and CAPAs more consistent, clear and usable.
Audit readiness
Prepare teams, evidence and systems for supplier, customer and regulatory inspection activity.
A clear sequence
Our consultancy process.
Understand
We clarify your organisation, objectives, risks and current constraints.
Review
We examine systems, documentation, evidence and the way work happens.
Prioritise
We set out immediate, recommended and future actions in a clear plan.
Embed
We support implementation and review outcomes with your team.
Strengthen your quality system.
Start with a focused conversation about the challenge in front of you.
Speak to a consultant