Our Regulatory & Quality Software
Our regulatory & quality software offer efficient and reliable solutions for managing regulatory compliance, quality control, and document management. Our software is designed to streamline processes, reduce errors, and increase productivity, ensuring that our clients meet regulatory requirements and maintain high-quality standards. With advanced features such as automated workflows, reporting, and audit Trials, our software solutions help our clients achieve compliance while improving efficiency and reducing costs.
NextGen eCTD
NextGen eCTD software is a robust, fully compliant, web-based software to create, manage, compile, publish, review, validate and archive the dossier in eCTD format for all eCTD accepting countries i.e. USA, EU, UK, Canada, Australia, South Africa, GCC, Jordan, Thailand, Switzerland and ECOWAS with Regulatory (Regional and ICH) specifications, validation, and compliance.
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NextGen SPL
NextGen SPL software is a robust, fully compliant, web-based software to create, manage, generate, review, and archive the SPLR4 in XML format for the USA in PLR (Physician Labeling Rule)/Non-PLR format for OTC, Rx and Cosmetic Product with maximum COL (Content of Labeling), PDP (Principle Display Panel), DLD (Drug Listing Data Element) validation and compliance as per the current and proposed SPL HL7 specifications and guidance.
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NextGen PDF Plugin
NextGen PDF Toolbox is an advanced productivity plug-in/add-on for Adobe Acrobat that is designed specifically for pharmaceuticals and life sciences industry to automate and expedite PDF documents processing (manual tasks to automation i.e. bookmarking, hyperlinking, ToC generation, page numbering, scale PDF along with batch operations function for eCTD/NeeS Publishing activities as per the Global Health Authorities requirements).
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NextGen eDQR
NextGen eDQR is a web-based software that allows you to create, author, review, track (the progress of each document) and approve the documents for regulatory submissions in CTD, eCTD, ACTD and Country Specific Health Authorities requirements with Lifecycle Management – from document creation and until post submission archival of documents in repository.
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NextGen eLN
NextGen eLN (Electronic Lab Notebook) is a web-based, digitize versions of paper notebooks, used to collect and organize R&D and ARD Laboratory data for the entire product lifecycle (start from project documentation and acquisition to sequence design, sample management, process management, and reporting by reducing noncompliance and effectively improve data. quality and productivity).
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NextGen Ticket Tracker
NextGen Ticket Tracker is a unified software tool that helps clients to resolve software issues by streamlining the resolution process. The elements they handle, called tickets, provide context about the issues, including details, categories, and any relevant tags. This will allow to access to a centralized repository for change implementation management with effective work-flow to notify stakeholders for tasks assignment and status.