Regulatory Solutions
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How To Achieve Timely Migration Of Your TMF
9/18/2023
This precise, proven methodology delivers a high-quality migration of your Trial Master File to the destination system, typically just 4-6 weeks after receiving all documents from the source system.
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FDA & ex-U.S. Product Approval
8/2/2023
Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.
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Phase 2 Clinical Trials: What to Include (And What To Leave Out)
8/2/2023
How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.
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Solutions For Health Authority Inspection Readiness And Remediation
7/26/2023
Unearth how Advarra identifies proactive solutions to minimize noncompliance risk, prepares teams for regulatory inspections, and provides competency for FDA and EMA inspection readiness.
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Frozen Packaging Solutions
6/21/2023
Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.
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Drug Accountability And Returns Management
6/8/2023
See how sponsors are using electronic solutions for Drug Accountability (DA) and experiencing significant increases in efficiency and accuracy that these methods provide.
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End-To-End Safety Solutions Designed For Success
6/6/2023
As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.
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Strategic Regulatory Documentation Practice
5/31/2023
Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.
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Only Elligo Mitigates Research Risk
4/18/2023
Uncertainty is inherent in clinical research. Uncover new strategies and solutions to alleviate risk so clinical teams can confidently and quickly bring products to market.
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Scalable Manufacturing Of Sterile Drug Products
3/31/2023
Discover comprehensive clinical to commercial scale manufacturing services that deliver true life-cycle management for sterile drug products that bring treatments to patients with efficiency and quality.