Quality Assurance Services

The main Quality Assurance services areas include:

1. Quality Management Systems (QMS)

   • QMS gap analysis and/or remediation

   • Initial QMS establishment and strategic QMS development

   • QMS harmonization and simplification projects

   • Governance of central quality systems; definition, collection and analysis of quality system metrics

2. Quality Operations

   • Responsible Person/Qualified Person (RP/QP) services

   • GxP supplier and quality agreement management

   • Management of process improvement/change initiatives and new product introductions

   • Batch record reviews

3. Quality Compliance

   • Acting as auditor for internal and supplier audits

   • Mock inspections and inspection readiness

   • Remediation of gaps/non-compliance

   • Regulatory intelligence support

4. Medtech and Combination Product Quality

   • Compliance Assessments for Medical Devices and Combination Products (MDCP) (US, EU, CH)

   • Design, planning and execution of compliance strategies for EU MDR, including Article 117 Notified Body Opinions, and US FDA 21 CFR Part 4 Compliance

   • Providing training on applicable regulations, such as US FDA 21 CFR Part 4, EU MDR, ISO 14971, ISO 13485, etc.

   • Developing Risk Evaluation and Mitigation Strategies for MDCPs