Halloran Solutions
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Organizational Assessment For A Large MedTech Company
6/5/2025
Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.
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GxP Quality Assessment And Remediation
9/16/2024
Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.
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Regulatory Special Designations
8/16/2024
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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Investigational New Drug Application Support
7/24/2024
When faced with industry pressures, companies seek out essential support to ensure their product's market plan is grounded in expert guidance.
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GxP Data Integrity: Assessment, Readiness, And Compliance
7/24/2024
Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.
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Why Regulatory CMC Strategy Is Crucial To Drug Development Projects
7/12/2024
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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Inspection Readiness
6/18/2024
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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Strategic Advising For Lifecycle Development: Navigating Complexity With Precision
5/15/2024
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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New Drug Applications And Biologics License Applications
4/15/2024
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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Trial Rescue: Leadership Approach To Propel Clinical Development
2/16/2024
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.