![]() Intuitive visual indication for lifecycle operations and status.Powerful and fast search on submission metadata and document titles.Filters for modules – see only the modules you want to see.Exposes all metadata for repeating sections, e.g.Multi-tab design: Keeps multiple documents open and organized.Table of Contents View: Compliant with electronic Common Technical Document (eCTD) and regional section headings.Regional specifications: Health Canada, European Union/EMA, Japan/NIHS, Switzerland/SwissMedic, Taiwan/FDA and U.S./FDA, Saudi Arabia/GCC and South Africa/MCC.Supports the latest international and regional eCTD specifications and is backwards-compatible with earlier specifications. ![]() Any eCTD submissions, even those produced by other software vendor’s publishing tools, can be viewed through ROSETTA Phoenix, as long as they conform to ICH and regional eCTD specifications. It’s compliant! ROSETTA Phoenix is compliant with the latest eCTD specifications and is backwards-compatible with previous specifications from ICH and Canadian, E.U., Japanese, Swiss, Taiwanese, and U.S. Which is subject to human or process errors when there is a new eCTD submission.įour of the world’s largest pharmaceutical companies and other mid-size companies have chosen ROSETTA Phoenix Enterprise Edition as their global standard of viewing eCTD submissions primarily because of its fast loading capability. ![]() In terms of the loading speed and the time it takes to construct the full lifecycle current and cumulative views.įurthermore, it does so without having to rely on any pre-built proprietary formats that need to be “refreshed” Many companies select ROSETTA Phoenix eCTD viewer over other viewers because it outperforms other eCTD viewing/reviewing software ROSETTA Phoenix’s smart eCTD loading and processing engine is among the fastest in the industry. It’s fast! It’s easy on the outside but fast on the inside! This is why our customers choose ROSETTA Phoenix for viewing eCTD submissions, even though they may use another vendors’ eCTD publishing software. There is no doubt that eCTD publishing software is cumbersome for general users. Most users can start using and enjoying ROSETTA Phoenix eCTD viewer without any training. ROSETTA Phoenix does not use any jargon or functionality restricted only to those who assemble,Ĭompile or publish eCTD submissions. It’s easy! You don’t need to learn a new language to use ROSETTA Phoenix.ĭesigned for the sole purpose of viewing eCTD submissions, ROSETTA Phoenix is specifically for users who do not need to ROSETTA Phoenix™ eCTD Viewer is a feature-rich yet easy-to-use eCTD viewer for viewing regulated submissions prepared in Electronic Common Technical Document (eCTD) format. ![]() I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help yourĬompany successfully adopt the eCTD. To educate authors, project teams, and Regulatory staff about granularity and document lifecycles. The best way I’ve found to teach these concepts is by using an eCTD viewer. Granularity until they’ve seen them in action. PHOENIX VERSION 8."It’s hard for most people to grasp important eCTD concepts like lifecycle and Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug submissions. It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. Phoenix WinNonlin is used by over 10,000 scientists at more than 1,500 establishments in 60 countries. Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench. PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation.
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