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
Halloran’s Feedback On FDA’s Electronic Systems, Records, And Signatures Guidance
The Clinical Operations Retreat for Executives (CORE West) recently brought together leaders in the life sciences sector to explore the modernization of clinical trials. Review attendees' feedback from an interactive workshop where the U.S. Food and Drug Administration's latest draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations” was discussed.
THOUGHT LEADERSHIP
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![halloran nda bla thumb]( "Success Planning For An Original NDA/BLA Submission")
Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).
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![GettyImages-1474723816 health files]( "Should You Bring Your Trial Master File In-House?")
The decision to bring the TMF in-house or contract with a CRO depends on the specific needs and resources of the sponsor, and it is important to carefully consider the implications before making a decision.
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![Medicine-pills-tablets-GettyImages-545993684]( "Preparing Now For FDA’s START Program For Rare Disease Drug Developers")
Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.
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![GettyImages-91598774 international]( "Bringing In Vitro Diagnostics To Market With Real-World Evidence")
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.
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![Microscope of cell, Embryonic stem cell]( "5 Broad Implications For FDA’s Project Optimus")
While formal guidance on the reform the dose optimization and dose selection is still pending, review five common themes that could help sponsors prepare for these changes.
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![AI-Artificial-Intelligence-GettyImages-1364859722]( "The Value Of Artificial Intelligence To Support Inspection Readiness")
Review three common inspection findings for overseeing all data and processes and ways that Artificial Intelligence can be integrated into an inspection readiness strategy.
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![GettyImages-1427845964 diversity workshop]( "Diversity In Clinical Trials: Shifting To Innovation Opportunities")
Get an overview of the evolving landscape of clinical trials, where diversity and inclusivity are increasingly recognized as vital components of effective and comprehensive healthcare research.
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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![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.
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![GettyImages-1149286442 strategy trials]( "Trial Rescue: Leadership Approach To Propel Clinical Development")
Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.
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![GettyImages-1394446062 regulatory]( "Regulatory Portfolio Management: From Bad To Gold")
Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.
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![GettyImages-887882750 global consulting]( "Experience The Halloran Difference")
By reviewing this established network of repeat customers and best-in-class partners, unearth how companies have been able to maintain effective interactions with regulatory agencies.
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![Field Service Consultants]( "Expertise From Concept To Commercialization")
Learn how we can customize our approach for every engagement, helping clients from the pharmaceutical, medical device, and biotech spaces reach pivotal milestones with success.
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![GettyImages-1333253892-doctor-legal-regulatory]( "Regulatory Operations Support")
With the right partner, learn how you can begin addressing document preparation requirements, document formatting, PDF publication, eCTD compilation, and submission needs through the FDA's Electronic Submissions Gateway (ESG).
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![GettyImages-950086574 drug development]( "Orphan Drug Designations")
Get unique insights into current expectations set by the U.S. Food and Drug Administration and the European Union, as well as distinctions between Orphan Drug Designation (ODD) criteria for the two entities.
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![Team meeting boardroom]( "New Insights Into FDA Meetings")
Having led or supported approximately 22 formal meetings with the FDA annually, discover how Halloran has helped companies craft regulatory strategies, prepare documentation, and orchestrate FDA discussions.
