Halloran Solutions
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GxP Data Integrity: Assessment, Readiness, And Compliance
4/24/2024
Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.
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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.
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Regulatory Portfolio Management: From Bad To Gold
10/30/2023
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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Experience The Halloran Difference
10/30/2023
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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Expertise From Concept To Commercialization
10/30/2023
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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Regulatory Operations Support
10/30/2023
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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Orphan Drug Designations
10/30/2023
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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New Insights Into FDA Meetings
10/30/2023
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.
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Inspection Readiness
10/30/2023
Learn how your company can enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.