Regulatory Solutions
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TrialScope Intelligence Disclosure Regulatory Tracking
3/23/2023
TrialScope Intelligence provides global coverage, monitoring countries with and without current disclosure requirements and sending alerts for changes in regulations. English translations and expert analysis create additional context and further understanding of regulatory expectations.
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See How You Can Start Your Early Phase Program 6-9 Weeks Earlier In Canada
3/23/2023
Vice President of Business Development Lisa Sanford explains whether you need an IND before starting your first-in-human trial in Canada.
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IRB Services For Institutional Sites
3/2/2023
Advarra can serve as your partner for everything from single investigational sites to multisite research consortia and therapeutic networks.
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Meeting Compliance Without Compromise
2/23/2023
Discover how services provided by the Institutional Review Board can assist institutions, academic research organizations, research consortia, and health systems.
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CRO Of Choice For Cell And Gene Therapies
2/17/2023
Whatever a study’s unique considerations – patients, products, process, follow-up, regulatory – Veristat can successfully get you through it.
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Navigating Early Phase CNS-Active Drug Development
2/14/2023
Early development of CNS-active drugs requires in-depth clinical expertise. Altasciences’ Dr. Beatrice Setnik, Chief Scientific Officer, examines the strategies to ensure early comprehensive data collection to fulfill regulatory requirements and aid in evaluating the risk/benefit profile.
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Biorasi Puts You On The Path To Successful Regulatory Approval
2/3/2023
Every journey needs a guide. Let’s talk about an effective regulatory strategy for your next clinical trial.
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NDA-Enabling Studies
1/26/2023
For over 25 years, we have been designing and running a broad range of early phase studies required for NDA submissions. We are experts in the design and conduct of early clinical development plans and stand-alone studies.
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Clinical Solutions For Early Phase Drug Development
1/25/2023
Altasciences provides expertise in all clinical pharmacology studies required for regulatory submission across a wide range of therapeutic areas.
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Expert Regulatory Filings To See Your Regulatory Strategy Through
1/18/2023
Veristat’s regulatory publishing team offers extensive expertise across the full scope of regulatory requirements.