Audit-Ready. Inspection-Ready.
Fully Compliant.
Senior-level GCP and PV Quality Assurance support for biotech, pharma, and CROs—helping you identify risks, close gaps, and stay ahead of regulatory expectations.
Trusted QA expertise across biotech,
pharma, and CRO environments
20+ years QA experience
Global audits across sponsors, CROs, and vendors
Expertise in ICH GCP, PV, QMS, RBQM
Where Most Organisations Struggle
- SOPs not aligned with ICH GCP E6(R3)
- Lack of effective vendor/CRO oversight
- Audit or inspection findings repeating
- No structured RBQM framework
- Gaps in data governance and oversight
- Limited internal QA resource or leadership
These gaps don’t just increase risk; they delay studies,
impact data integrity, and expose your organisation during inspections.
impact data integrity, and expose your organisation during inspections.
How We Support You
- Identify and prioritise critical compliance gaps
- Prepare your organisation for audit and inspection success
- Strengthen vendor oversight and governance frameworks
- Build and optimise fit-for-purpose QMS
- Provide senior QA leadership without full-time cost
Not sure if you’re inspection-ready?
Download our ICH GCP E6(R3) Sponsor Checklist
Used by QA leaders across biotech & pharma
Proven QA Impact
CRO Qualification Audit
Identified critical gaps in vendor oversight and SOP governance, enabling the sponsor to mitigate inspection risk and strengthen oversight controls.
SOP Gap Analysis (ICH GCP E6 R3)
Conducted full gap assessment of sponsor SOPs, identifying deficiencies in RBQM, data governance, and vendor oversight.
PV Vendor Oversight
Strengthened oversight model and escalation processes aligned with GVP expectations.
Who We Work With
Biotech startups entering clinical trials
Small to mid-sized pharma
CROs requiring QA support
Organisations preparing for inspections
Preparing for an Audit or Inspection?
Get expert QA support to identify risks, close gaps, and ensure compliance.