Regulatory Solutions
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Human Abuse Potential
4/17/2024
With over 60 HAP studies successfully conducted in the last decade, Altasciences has experience in diverse areas such as for stimulants, opioids, and sedative-hypnotics.
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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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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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IQVIA 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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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.