At Saolyn, we support organisations operating in regulated and technical environments with expert-led, systems-based services. From compliance and quality management to audit oversight and AI integration, we deliver structured solutions that align with your standards, support your people, and scale with your business.

Audit & Advisory

We deliver independent, systems-aligned audit services across regulated sectors, supporting both certification and internal improvement objectives.
Professional services include:
  • Internal audits aligned to ISO 13485, and ISO 9001
  • Readiness and gap analysis for certification or regulatory compliance
  • Audit preparation for surveillance and recertification audits
  • Corrective action review and remediation planning
  • Customised audit frameworks and risk-based scoping tools

System Design & Optimisation

We work with clients to design, optimise, or remediate operational and compliance systems to meet international standards, customer expectations, and internal objectives.
Professional services include:
  • Quality Management System (QMS) architecture and design
  • Process mapping, SOP development, and documentation control
  • Policy and procedure alignment with ISO, TGA, or client-specific requirements
  • Implementation of low-code automations to improve traceability, efficiency, and oversight

Compliance & Documentation

We support the development, maintenance, and improvement of operational compliance systems and controlled documentation in alignment with regulatory and standards-based requirements.
Professional services include:
  • Technical file development and structured document control
  • Risk registers, issue tracking, and audit trail design
  • CAPA management, including investigation, planning, effectiveness review, and closure
  • Root cause analysis facilitation (e.g. 5 Whys, Fishbone, Pareto)
  • SOP and work instruction drafting across teams and functions
  • Supplier approval and quality assurance workflows

Fractional & Embedded Advisory

We assist clients in managing third-party and internal supplier risk through targeted, standards-based auditing programs and supplier performance systems.
Professional services include:
  • First-party (internal supplier) audit programs
  • Third-party supplier audits aligned to ISO 13485, ISO 9001, and GMP
  • Risk-based supplier categorisation, scoring, and performance tracking
  • Industry-specific audit checklist development and delivery
  • CAPA support, audit documentation, and regulator-ready reports

Supplier Risk Management, Auditing & Compliance 

We offer fractional or embedded quality and compliance advisory services, tailored to support internal teams on a flexible, as-needed basis.
Professional services include:
  • Interim or ongoing QMS leadership and governance
  • Internal auditor or quality advisor on-call services
  • Team coaching and compliance briefings
  • Oversight across multiple projects or product streams
  • Planning and facilitation of ISO-compliant management reviews

AI Integration & Applied Intelligence

We help organisations safely and strategically introduce AI and automation into operational, compliance, and reporting workflows.
Professional services include:
  • AI readiness assessments and risk evaluations
  • Use case development and implementation planning
  • Integration of AI tools into existing platforms
  • Low-code workflow automation for audit, documentation, and task tracking
  • Support in AI governance, responsible use policy creation, and staff enablement