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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.


  • 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 […]

  • Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form (ICF) that best facilitates the informed consent process? If you are, you’re not alone. If you aren’t, you should be. During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the […]

  • In April of this year, the U.S Food and Drug Administration (FDA) released “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.”  This guidance is noted to expand on the prior guidance for industry, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” released in August 2013 and to […]