Regulatory Solutions
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psiXchange: Intelligent, Automated Safety Document Distribution Software
3/15/2024
Discover how psiXchange streamlines the distribution, tracking, and acknowledgment of key safety documents, saving time, resources, and costs for global drug manufacturers and research organizations.
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Accelerated Clinical Trial Disclosure Starts Here
2/20/2024
See why TrialScope Disclose is trusted by 16 of the top 20 industry clinical trial sponsors for optimizing, streamlining, and simplifying the clinical trial disclosure process from registration to results.
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APAC Biopharma: Bridge The Gap To The US FDA
2/8/2024
Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.
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Safety And Regulatory Compliance Solutions
1/29/2024
IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.
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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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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).