ABOUT HALLORAN CONSULTING GROUP
Halloran Consulting Group, a ProductLifeGroup company, is a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support in the pharmaceutical, biotechnology, and medical device sectors in the United States. Founded in 1998 by Laurie Halloran, the company is known for offering comprehensive solutions to help clients navigate complex regulatory environments, optimize operations, and accelerate product development. The Halloran team empowers clients to achieve critical business milestones, ensure product quality and safety, and maintain competitive advantage in highly regulated environments. The company has a bi-coastal presence with offices located in Boston, MA and San Diego, CA. Their team of subject matter experts takes a customized approach to each engagement, effectively guiding their clients toward their next pivotal moment. They are trusted industry partners whose expertise offers operational excellence and fosters innovation across the life sciences ecosystem. Their goal is to support clients and the patients they serve.
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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![deadlines time management-GettyImages-1350531674]( "Ticking Timeline: Tips For Effective Product Development Timelines")
Biotech and pharmaceutical companies must establish clear product development objectives and well-designed timeline to navigate the drug development lifecycle effectively.
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![GettyImages-1221852665-not tested on animals]( "How The FDA Is Phasing Out Animal Testing Requirement")
The FDA is embarking on a transformative initiative to phase out animal testing requirements.
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![Digital Globe]( "Key Update On Guideline For Good Clinical Practice E6(R3)")
Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.
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![Risk Management-GettyImages-665231256]( "Pathway To Success: How De-Risking Life Sciences Companies Leads To Investment Growth")
De-risking in clinical development is essential to optimizing trial success and ensuring regulatory approval and strategic decision-making at critical points in a study’s lifecycle can minimize uncertainties.
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![GettyImages-1398569507 regulatory]( "Groundbreaking Rare Disease Drug Approval (OGSIVEO [nirogacestat])")
Strategic guidance helped SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, to refine their regulatory strategy for late-stage development.
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![GettyImages-16311317-Australia-Map]( "Bridging Continents For Clinical Development")
By leveraging Australia's ecosystem as a launchpad, organizations managing both early-stage and advanced development can enhance trial quality and position themselves for success.
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![GettyImages-1134679866 inspection]( "Turning Your Inspection Fears Into Actionable Readiness Steps")
Inspection readiness is a vital component of achieving FDA approval for drugs and devices, yet even seasoned clinical research professionals can face challenges in navigating the evolving regulatory landscape.
CONTACT INFORMATION
Halloran Consulting
22 Thompson Place
Boston, MA 02210
UNITED STATES
Phone: 978.482.6237
Contact: Gail Winslow, Head of Marketing
CALIFORNIA ADDRESS
3040 Science Park Road, Suite 1300
San Diego, CA 92121
PRESS RELEASES
- ProductLife Group (PLG) Acquires Halloran To Further Expand Its Global Reach And Capabilities To Support The Development Of New Therapies
- 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.
