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01 The Best eCTD Viewing System to End Review Anxiety Are You Suffering from eCTD Review Fatigue? If your Regulatory Affairs team feels a constant knot of anxiety when facing a final submission, you're not alone. That sinking feeling—the result of slow software, cluttered interfaces, and the fear of a missed hyperlink—is what we call [...]
Translating Strategic Goals into Operational Excellence Strategic Pillar (Goal) Key Challenge Cited in Workshop DnxtSolutions Value Proposition Operational Scalability No systematic approach to answer agency questions (RTQ Management). Implement Robust RTQ Infrastructure:Â Define workflows, triage, and response standards to ensure timely approval and a robust, scalable process. Data as a Strategic Asset Data fidelity issues and [...]
