Services – MSAQS

Our QA Services

We provide expert, risk-based QA support across the clinical development lifecycle, tailored to your organisation’s needs.

GCP & PV Audits

• Vendor audits
• Investigator site audits
• System and process audits
• Routine and qualification audits

Independent, risk-based audits that provide clear visibility of compliance strengths, gaps and potential inspection risks. We support vendor, site, system, process, qualification and routine audits across GCP and PV activities.

SOP Development & Gap Analysis

• SOP creation and lifecycle management
• Gap analysis against ICH GCP E6(R3) and GVP
• QMS development and optimisation

Clear, practical SOP and QMS support aligned with current regulatory expectations. We help create, review and improve controlled documents so processes are compliant, usable and inspection-ready.

Inspection Readiness

• Mock inspections
• Inspection preparation and support
• CAPA strategy and remediation

Preparation support to help teams, systems and documentation stand up to regulatory inspection. We identify gaps, support remediation and build confidence across key inspection areas including TMF, oversight, CAPA and essential records.

Vendor Oversight

• Vendor qualification and governance frameworks
• Oversight models aligned with regulatory expectations
• Risk-based vendor management

Practical vendor oversight support to ensure outsourced activities remain controlled, documented and inspection-ready. We help strengthen governance, monitor vendor performance and identify risks before they become compliance issues.

QA Leadership & Consultancy

• Interim QA leadership
• Strategic QA support
• QMS implementation and continuous improvement

Strategic QA leadership to strengthen quality systems, improve governance and support confident decision-making. Ideal for growing sponsors, biotech companies or teams needing senior QA input without a full-time appointment.

Flexible or Project Specific QA Support

• Targeted QA expertise to execute critical initiatives on tight timelines
• Rapid-response QA support for emerging risks, urgent issues, and evolving regulatory requirements across regulated operations.

Senior QA support when you need additional expertise, fast. We help deliver critical projects, manage urgent quality issues, close compliance gaps and support evolving operational or regulatory needs without the commitment of a permanent hire.