
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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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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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 in competitive global markets.
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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.
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Clinical research advances healthcare, but access, opportunity, and technology are vital to overcoming barriers and improving outcomes.
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Leaders in the clinical trials field answer questions about transitioning from clinical development to commercialization and the strategic foresight, operational excellence, and adaptability required.
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Moving from pre-IND to IND involves preparing for FDA interactions with a focused pre-IND meeting request and package, Selecting the right CRO, and ensuring data integrity.
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When transitioning from research to development it's important to thoroughly understand FDA requirements and engage the FDA early on, and create an efficient integrated development plan.
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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Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.
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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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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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Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.
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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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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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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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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.