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Four services. One accountable partner for your compliance programme.
From a single-site GMP audit to an ongoing multi-country compliance programme, every engagement is staffed from the same specialist consultant panel and held to the same reporting standard.
SERVICE / 01 GMP Audit
On-site and remote Good Manufacturing Practice audits benchmarked against FDA, EU-GMP and WHO expectations, run by an auditor matched to your dosage form and therapeutic area.
- Pre-audit scope and document review
- On-site or remote facility assessment against GMP
- Findings classified and scored to a consistent standard
- CAPA tracking through to close-out
RECORD NO. PCX/AUD/0142Facility Audit Summary
Compliant
Audit TypeGMP — On-site
Regulatory ScopeFDA / EU-GMP
Critical Findings0 Open
CAPA StatusClosed
Auditor Sign-offVerified ✓
RECORD NO. PCX/QMS/0309Quality System Health
Improving
SOP Coverage96%
Deviation BacklogCleared
CAPA Cycle TimeReduced
Inspection ReadinessMaintained
Review CadenceQuarterly
SERVICE / 02 Quality Systems That Stay Inspection-Ready
Ongoing support to build, maintain and continuously improve your quality management systems, so the file is always inspection-ready and not assembled in a rush beforehand.
- QMS gap assessment and remediation planning
- SOP development, review and version control support
- CAPA and deviation system strengthening
- Ongoing inspection-readiness support, not a one-off review
SERVICE / 03 Conducting GMP Auditing Services Worldwide
Independently authored GMP and GxP audit reports for supplier and site qualification, written by auditors with no prior relationship to the site being assessed.
- Independent auditor with no prior relationship to the site
- Report format accepted by regulators and client QA teams alike
- Suitable for supplier qualification and vendor requalification
- Recurring programme option across multiple suppliers or sites
RECORD NO. PCX/AUD/0142Facility Audit Summary
Compliant
Audit TypeGMP — On-site
Regulatory ScopeFDA / EU-GMP
Critical Findings0 Open
CAPA StatusClosed
Auditor Sign-offVerified ✓
How An Engagement Runs The same standard, whichever service you start with
Every engagement - audit, filing or QMS support - follows the same four-stage process.
A / 01
Scope the engagement
We align on regulatory framework, site or filing scope, and timeline before a single consultant is deployed.
A / 02
Deploy the right expert
A consultant with matching therapeutic, dosage-form and jurisdictional experience is assigned from our global panel.
A / 03
Do the work, document as you go
Assessment, filing or systems work proceeds against a shared standard, with findings or progress recorded as they happen.
A / 04
Report, close-out & hand-off
A complete report or filing package is delivered, with any CAPA tracked through to close-out and kept on file.