My Services

Independent GxP audits of CROs, vendors, and internal systems, plus inspection readiness support to ensure you are prepared when regulators arrive

When you would need this

When you need an independent view of your compliance status across CROs, vendors, or internal systems before regulators do

Typical deliverables include

Audit reports with clearly prioritized findings, risk-based observations, and practical, inspection-ready recommendations

Mock inspections, gap assessments, and remediation support to ensure you are inspection-ready at all times

When you would need this:

When you have an upcoming inspection or need confidence that your organization is prepared at any time

Typical deliverables include

Gap assessment summaries, mock inspection feedback, and targeted action plans to address inspection risks

Independent QA oversight of outsourced clinical programs, including CRO and vendor management from First-in-Human to Phase 3 and beyond

When you would need this

When your clinical program is outsourced and you need independent oversight of CRO performance and quality risk

Typical deliverables include

Oversight assessments, risk evaluations, and structured recommendations to strengthen CRO and vendor performance

Design and implementation of right-sized, inspection-ready Quality Management Systems

When you would need this

When you are building a QMS for the first time or need to strengthen an existing system that is not holding up in practice

Typical deliverables include

QMS frameworks, SOP structures, and implementation plans aligned to your organization’s stage and regulatory expectations

Assessment and remediation of data integrity risks across systems, processes, and vendors in line with regulatory expectations

When you would need this

When you are concerned about the reliability of your data or need to address data integrity risks across systems and processes

Typical deliverables include

Data integrity assessments, risk identification summaries, and practical remediation and control recommendations

Risk-based CSV and Part 11 compliance, including validation strategy, documentation, and oversight of GxP systems, including SaaS and vendor platforms

When you would need this

When your GxP systems require validation or Part 11 compliance without unnecessary complexity or documentation burden

Typical deliverables include

Validation strategies, gap assessments, and documentation frameworks aligned to Part 11 and Annex 11 expectations

Development of clear, audit-ready SOPs and GxP documentation aligned to regulatory expectations

When you would need this

When your procedures, validation documents, or audit responses need to be clear, consistent, and inspection-ready

Typical deliverables include

Clear, audit-ready SOPs, validation documents, and regulatory-facing documentation

Practical, role-based GxP training aligned to your systems, processes, and regulatory obligations

When you would need this

When staff need to understand their responsibilities and apply GxP requirements consistently in day-to-day work

Typical deliverables include

Role-based training materials, session delivery, and supporting documentation for training records and compliance tracking

Pharmacovigilance oversight and audit support delivered in collaboration with specialist PV partners

When you would need this

When you need pharmacovigilance oversight or audit support supported by specialist expertise through an established PV partner

Typical deliverables include

PV system assessments, audit outputs, and coordinated recommendations delivered in collaboration with specialist PV partners