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 Inspection Readiness Methodology: Failure To Plan Is A Plan To Fail
Health Authority inspections can occur anytime during a product’s lifecycle, making thorough preparation crucial for market approval. Unfortunately, sponsors often start preparing only when major milestones, like Biologics License Application (BLA) or New Drug Application (NDA) submissions, are near. This last-minute approach can lead to stress, overwhelmed teams, and avoidable inspection issues, potentially delaying development.
THOUGHT LEADERSHIP
-
![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.
-
![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.
-
![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.
-
![Halloran Recording 2]( "Inspection Readiness Methodology: Failure To Plan Is A Plan To Fail")
Join us to learn how to stay inspection-ready throughout the clinical trial process and enhance your chances of market approval for your product.
-
![GettyImages-1346675513 lab materials]( "Raw Material Control For Biotechs (Part 2): Clinical Development Considerations")
Take a deep dive into several strategies being used to enhance raw material control to facilitate successful regulatory submissions and commercialization efforts.
-
![Leadership=GettyImages-685797114]( "Leadership Considerations To Enable Clinical Development Success")
Explore several leadership examples that underscore the value of assembling the right expertise across organizations, facilitating successful outcomes, and cultivating a favorable track record for future investment opportunities.
-
![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).
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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
