ABOUT HALLORAN CONSULTING GROUP
Halloran Consulting Group is a life science consulting firm offering services across five expertise areas, enabling the end-to-end development lifecycle, from discovery, through clinical & regulatory, to commercialization and product launch. Our deep bench of strategic advisors and hands-on consultants stand ready to serve your organization as a true partner in the quest of improving human health. Our expertise areas include: clinical development & operations, regulatory affairs & operations, quality & compliance, organizational excellence, data & technology, project leadership & program management. Let us guide you in future proofing your organization.
FEATURED ARTICLE
Three Key Impacts Of ICH E6(R3) On RBQM And Oversight
The drafted guideline ICH E6(R3), introduces significant updates impacting Risk-Based Quality Management (RBQM). Explore an overview of the three major ICH principles and key insights related to this guidance with an emphasis on identifying Critical to Quality factors early.
THOUGHT LEADERSHIP
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![Risk-GettyImages-1584439434]( "Three Key Impacts Of ICH E6(R3) On RBQM And Oversight")
The drafted guideline ICH E6(R3), introduces significant updates impacting Risk-Based Quality Management. Explore an overview of three major ICH principles and key insights related to this guidance.
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![laptop director hiring, employee, team GettyImages-1193107244]( "Leveraging Outsourcing And Mixed Model Staffing Amid Layoffs")
In the face of layoffs or data-driven disruptions, choosing to adopt outsourcing or a hybrid staffing model can offer substantial cost savings by reducing overhead expenses like salaries and benefits.
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![halloran cmc thumb]( "CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins")
In this presentation, speakers guide viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.
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![GettyImages-1180547358-computer-research]( "How, Why, And When To Apply For An Orphan Drug Application")
Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset.
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![GettyImages-656476590 conference event summit trade show]( "Catching Up With Consulting — DIA 2024 Insights")
Explore the insights and perspectives from the DIA 2024 Global Annual Meeting to stay informed on the latest advancements in clinical trials and regulatory landscapes shaping the pharmaceutical industry.
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![project approved checkmark-GettyImages-1470115316]( "How Regulatory CMC Experts Navigate Expedited Accelerated Approval Timelines")
CMC experts stress that, despite adjusted timelines, stringent manufacturing and characterization requirements for product safety and quality remain, necessitating proactive planning to meet deliverables within the expedited approval period.
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![Halloran recording 3]( "The Quality Equation: 4 Essential Components To Enable Drug Development Success")
In this episode, experts share their insights on the four essential components for achieving quality excellence in clinical trials.
CONTACT INFORMATION
Halloran Consulting
22 Thompson Place
Boston, MA 02210
UNITED STATES
Phone: 617.648.7879
Contact: Tania Zieja, President
CALIFORNIA ADDRESS
3040 Science Park Road, Suite 1300
San Diego, CA 92121
PRESS RELEASES
- Halloran Wins The Life Science Cares Transformative Partnership Award
- Halloran Celebrates 25th Anniversary Milestone
EXPERT RESOURCES
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![GettyImages-466728721 quality]( "GxP Quality Assessment And Remediation")
Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.
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![GettyImages-1002000796-lab-research-scientist-development]( "Regulatory Special Designations")
Discover how securing an FDA special designation can accelerate your drug development process and bring life-saving therapies to market faster.
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![Documentation Traps]( "Investigational New Drug Application Support")
When faced with industry pressures, companies turn to Halloran for essential support in their initial investigational applications. We provide a roadmap to ensure your product's market plan is grounded in expert guidance.
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![Personal data security-GettyImages-1172943967]( "GxP Data Integrity: Assessment, Readiness, And Compliance")
Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.
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![GettyImages-1296272795-plan-planning-strategy]( "Why Regulatory CMC Strategy Is Crucial To Drug Development Projects")
Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.
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![iStock-1275682432-inspection-regulatory]( "Inspection Readiness")
Learn how your company can enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.
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![Field Technologies Trusted Advisor]( "Strategic Advising For Lifecycle Development: Navigating Complexity With Precision")
Discover tailored strategies crafted to align with your company's goals and objectives that draw upon extensive past, present, and ongoing experiences to drive success at each pivotal stage of your journey.
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![iStock-1288116976-regulatory-compliance]( "New Drug Applications And Biologics License Applications")
Compiling a submission meeting stringent regulatory standards requires a partner who comprehends the regulatory landscape and can craft a compelling narrative aligned with FDA expectations.
