Regulatory Solutions
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Full Service CRO And Regulatory Partner For Biologics
1/25/2024
Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.
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Strategic Regulatory Consulting & Planning
1/25/2024
Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.
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Advarra Connect
1/19/2024
Discover a new way to streamline document management and guarantee compliance with regulatory standards, providing a robust and user-friendly solution for optimizing research processes.
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Global News And Expert Analysis On Pharma Policy And Regulation
12/18/2023
Since 1939, see how Pink Sheet has helped sponsors stay on top of critical developments in today’s complex pharma regulatory environment.
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Clinical And Regulatory Strategy
11/7/2023
Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 43.5% R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.
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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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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.