Quality Assurance (QA)
and Compliance

At PRG Integrated, we understand that the quality management system is the foundation for safe, effective products and satisfied consumers. PRG Integrated can develop or enhance your quality management system tailored to your needs. Additionally, PRG Integrated conducts mock audits to ensure ongoing compliance. By optimizing our client’s quality assurance practices, our client’s will save company time, money, and improve customers confidence in your product. Quality assurance is an on-going commitment that can improve our client’s ROI and ensure consistent/ reliable product supply.

PRG Integrated provides Quality Assurance (QA) and Compliance Services that ensure the client’s Quality Management System (QMS) meets current regulatory requirements and is tailored align with the client’s business needs.

PRG Integrated utilizes a hands-on and risk-based approach to improve quality and compliance, while implementing practical solutions for your organization. By working with our client’s Quality and Business teams, we reduce the risk of QMS knowledge transfer and ensure seamless improvement in your Quality processes and programs. PRG Integrated’s quality assurance professionals strive to enhance your internal capabilities to ensure all aspects of the client’s QMS are effective and efficient.

OUR SERVICES INCLUDE

  • End-to-end Quality Management System design, assessment, and remediation, including adaptation to meet changing regulatory and industry expectations
  • Audits/Assessments, including GMP gap assessments, internal audits, supplier audits, due diligence assessments, and mock FDA inspections
  • Business/product acquisition and divestiture quality strategies and plans
  • On-site quality oversight and consultancy/human capital solutions
  • Regulatory inspection readiness, including response design
  • Root cause investigations and Corrective and Preventive Action (CAPA) planning and execution
  • Validation planning strategy development and review
  • GMP training for executives, management, and staff