Quality & Compliance Consulting
How we help with Quality & Compliance Consulting
Halloran designs right-sized Quality Management Systems to document processes, procedures, and responsibilities for achieving quality policies and objectives based on the size and operating model of our clients. We develop quality system documents using our lean principles to guide structure, content, and style. Our quality system design and development support activities include establishing QMS governance structure and management review processes, establishing quality implementation support across risk management activities, product and process validation, investigations and CAPA, complaint management, and post-market support.
Halloran has designed and implemented Quality Management Systems (QMS) across more than 250 plus life science companies of varying sizes and stages of development.
Halloran’s employees are former industry leaders with extensive experience assessing, developing, and implementing Quality Management Systems for all company sizes from small start-ups to large global commercial enterprises.
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Quality Governance and Evolution of Quality Management Review
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The International Council for Harmonisation draft guideline, ICH E6(R3), released on May 19, 2023, provides implications for Risk-Based Quality Management (RBQM). Considering the updates, John Sikora, Associate Principal Consultant at Halloran presented at Momentum’s annual GCP Inspection Readiness conference. John’s presentation, “Examining the Impact of ICH E6 (R3) on RBQM, Oversight Procedures and GCP Inspection […]
