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FOCUS ON REGULATORY & COMPLIANCE |
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By Erin Harris, Editor-In-Chief, Cell & Gene | Connecting scientific advances with scalable manufacturing, rigorous evidence, and regulatory strategies can help bring therapies to patients. | |
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| Comparing NHP And VHP For Isolator Decontamination | White Paper | Esco Lifesciences | Compare Nebulized Hydrogen Peroxide (NHP) and Vaporized Hydrogen Peroxide (VHP) efficacy, cycle times, and validation challenges inside pharmaceutical isolators to optimize your aseptic processing turnaround. |
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| The Missing Coordination Layer For Laboratory Systems | Webinar | Revvity Signals Software, Inc. | Improve workflow coordination across lab systems with better visibility, automated decision logic, audit-ready traceability, and repeatable processes that help teams move work more efficiently. |
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| The Continuing Challenge Of Drug-Induced Liver Injury | Article | Emulate | Recent liver safety concerns highlight the limits of conventional preclinical testing. Human-relevant models could help researchers detect drug-induced liver injury earlier and reduce costly setbacks. |
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| What Recent FDA CRLs Reveal About Stability | White Paper | Solvias | Understand new insights about stability testing, how it impacts manufacturing, distribution, and supply chains, and how to build a stronger program in this analysis of recent FDA Complete Response Letters (CRLs). |
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| Harness An Adept IRB's Expertise To Streamline Study Design | Article | By Raffaella Hart and Linda Reuter, BRANY | An Institutional Review Board protects human research participants by evaluating study ethics, consent, and risks, while providing sponsors with ongoing guidance on complex trial protocols. |
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REGULATORY & COMPLIANCE SOLUTIONS |
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