Regulatory Solutions
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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.
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GxP Auditing, Compliance, And Specialized Consulting
10/26/2023
Advarra’s experts can work directly with your team to provide global consulting and evaluation services related to research, clinical quality assurance, regulatory compliance, and human research protection.
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IRB Solutions To Empower Better Research Programs
10/18/2023
Irrespective of a project's scale, therapeutic focus, or the size of its investigative team, discover how Advarra works to stand as a trusted partner in conducting efficient and responsible research.
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eISF: Industry Standard eRegulatory Software For Clinical Sites
10/6/2023
Modernize your study binder processes with Florence eBinders™, offering remote access for sponsor interactions, monitoring, and source data review.