Ectd viewer

Built on top of ROSETTA Phoenix eCTD Viewer's intuitive user interface, ROSETTA Annotation and Collaboration Services (RAACS) adds capability to annotate on eCTDs and manage review process for eCTDs right within the ROSETTA Phoenix eCTD viewing environment. It does so without altering submission documents or eCTD backbones in any way. Integrated with ROSETTA Phoenix eCTD Viewer, ROSETTA Annotation and Collaboration Services (RAACS) provide reviewers the capability to annotate on eCTD submissions, create, assign and manage tasks related to the internal review of eCTDs within the same, intuitive user interface of ROSETTA Phoenix. It does so without altering eCTD submission documents or eCTD backbones in any way. Furthermore, RAACS is a publishing tool neutral implementation - it works with any published eCTD output produced in-house or outsourced by any eCTD-compliant publishing tools. RAACS is also an EDMS-neutral implementation. When integrated with ROSETTA Phoenix Server with EDMS Connectors, RACCS allows reviewers to work on eCTD submissions stored on a file share or in EMC Documentum, OpenText Livelink, and Microsoft SharePoint, in the same way - no additional training required. With its publishing tool and EDMS neutral implementation, RAACS can greatly improve the collaboration in the review of eCTDs between affiliates and outsourcing partners globally. It also reduces the cost of training for different eCTD review tools. Consistent with ROSETTA Phoenix's user-friendly user interface, RAACS provides highlighting effects, QC status icons, one-click access to filters and eCTD reviewing tools to allow reviewers to focus on the jobs at hand conveniently and efficiently. See feature highlights on the right-hand side for more details. Integrated with ROSETTA Phoenix, a full lifecycle eCTD viewer Annotate on eCTD documents and the eCTD structures Create, assign and manage tasks during and after internal review process Quick access to status reporting tools Highlighting effects for easy identification of documents

Collaborate your eCTD compilations Submit faster in teams - merge compilation from your team members. Icon Create pCTD from eCTD Quick conversion of an electronic submission to paper. Additional tools Various productivity tools included in Mono eCTD Office ensure your work continues flawlessly. Need PDF editing (OCR, bookmarks, TOC generation, security, fast web view, ...)? Included. Need to compare PDF documents? Included. Need to compare two sequences? Included. Need to check your entire set of PDF documents for broken hyperlinks? Included. PDF Editor / Pharma Toolbox, PDF Hyperlink Optimizer, Submission Comparer. Validate & View Prior to filing your electronic submissions to regulatory agencies you should make certain your sequences are technically valid. Streamline you review process, reduce response times to Agency requests, and ensure faster approvals for your products. Mono eCTD Validator and Mono eCTD Viewer are included in Mono eCTD Office! Looking to support other regions, human or veterinary products? eCTD Australia Canada China European Union (+ UK) Gulf Cooperation Council Jordan Singapore South Africa Switzerland Ukraine United States World Health Organization NeeS Australia Bosnia and Herzegovina European Union (+ UK) Gulf Cooperation Council New Zealand Serbia "I want my Mono eCTD Office"

TH eCTD Compiler TH eCTD Compiler - FDA Thailand eCTD Publishing TH eCTD Compiler, a part of eCTD Office, is an authenticated eCTD preparation, validation, creation, manipulation, viewing and publishing software solution for Thai FDA electronic submissions. eCTD Office produces valid Food and Drug Administration eCTD electronic submissions. Fully compliant with TH eCTD specification Module 1 regional information. The main functionality of the TH eCTD Compiler is the creation of valid TH FDA electronic dossier submissions along with the lifecycle management. By using the TH eCTD Compiler and its change control process, several topics including regional-aware approved module 1 template, lifecycle management, attributes, granularity, and envelope values are addressed and solved. Built in validation supporting regional rules ensures no invalid submissions can be generated. Regularly updated following the changes in the Thai FDA / ICH eCTD specification. Mono eCTD Office's eSubmission Compiler Main Features Icon Affordable Save time and money with your next submission! Icon Understand eCTD Complex XML and other IT related features hidden from you! Icon Create valid eSubmissions Embedded Validation Criteria. Icon Create eCTD templates Speed up your work, create pre-populated compilations. Icon Convert MS Word to PDF at publishing Let eCTD Office take care of converting your Word documents to PDF. Icon Split / merge PDF documents Easily combine several PDF documents for a single published document. Icon Create / auto-correct PDF hyperlinks Ensuring your PDF hyperlinks are valid and functional. Icon Powerful PDF processing features Conversion to PDF version 1.4, optimization for fast web view, ... Icon Intuitive Interface Easy-to-use intuitive user interface. Icon ASMF submissions Open (applicant's) / Closed (restricted) part export for Active Substance Master Files (ASMF) submissions. Icon Automatic MD5 checksum generation Do not worry about high level programming aspects of an electronic submission. Icon Automated optimization Automatic optimization: removal of orphaned files and empty sections. Icon In-place validation A validation system that helps you resolve naming and other errors during compilation time. Icon Region-specific More than 250 ICH and specific regional validation rules. Icon Document merging Merging of existing eCTD submissions into a new / renewal submission with leaf operation re-assigning. Icon Country specific rules Customizable validation rules to allow the preparation of eCTD submission specific to your country. Icon Off-the-shelf No extra server components are needed for the system. Icon Automated creation and packaging Auto creation and packaging of eCTD compliant electronic submissions. Icon Reuse previous sequences Automatic attribute and envelope / regional metadata elements generation from previous sequences. Icon Quick access buttons Commonly used tasks such as submission validation, document merging, adding PDF cross-references. Icon Envelope elements Easy country specific envelope creation. Icon Import / export files from SharePoint / Documentum Connect to your prefered DMS. Icon Share /

Unlock stock picks and a broker-level newsfeed that powers Wall Street. In This Article: Enhancements enable pharma, biotech and generics companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics , /CNW/ -- Clarivate Plc (NYSE:CLVT), a leading global provider of transformative intelligence, today announced the launch of the newly enhanced Cortellis CMC Intelligence™ solution, featuring a new post-approval variations module. The module for post-approval variations covers regulatory changes across multiple countries, offering meticulously curated requirements to streamline tracking. With this update, pharmaceutical, biotech, and generics companies can effortlessly navigate the regulatory process and prioritize essential actions. (PRNewsfoto/Clarivate Analytics) CMC activities account for nearly 18% of the entire R&D budget, emphasizing the importance of optimization and validation. Cortellis CMC Intelligence for post-approval variations enables clients to compare requirements across 64 countries, reducing tracking time and increasing submission rates with organized, timely, and accurate information. Justin Hubbard, Vice President, Product Management, Life Sciences & Healthcare, Clarivate, said: "This enhancement underscores our commitment to simplifying the complexities of CMC regulatory dossier submissions for our clients. By offering transformative insights, Clarivate accelerates their path to markets and patients. With the ability to efficiently compare regulations across countries for small molecules and biologics, as well as automate CMC regulatory monitoring through user-configured alerts, clients can navigate the process with confidence." With its new module covering both pre- and post-approval documents, Cortellis CMC Intelligence offers comprehensive lifecycle information for drugs and biologics. Serving as a single-platform solution for CMC requirements, it effectively reduces tracking time and unnecessary costs. About Cortellis CMC Intelligence Cortellis CMC Intelligence curates and tracks official CMC regulations and local practices for more than 135+ countries, territories and organizations for small molecules and 64 countries, territories and regions for biologics, with pre-and post-approval module coverage. Robust data is available for 25+ product and regulatory-related filters based on eCTD structure, including 6K+ source documents and over 2K links to Cortellis Regulatory Intelligence, providing access to expanded detail and in-depth summaries from experts in local regulatory practices, paired with reference source documents, to offer a complete picture. The addition of a new post-approval module now makes a comprehensive CMC solution with complete lifecycle information for drugs and biologics to increase submission rates and avoid costly delays. To learn more about Cortellis CMC Intelligence, visit here.

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