Alternatives to KnowledgeNET

Compare KnowledgeNET alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to KnowledgeNET in 2026. Compare features, ratings, user reviews, pricing, and more from KnowledgeNET competitors and alternatives in order to make an informed decision for your business.

  • 1
    RegDesk

    RegDesk

    RegDesk

    With the ever-increasing complexity of global medical device registration regulations, more companies are turning to regulatory information management systems software (RIMS software) to streamline the application life cycle and manage medical device applications. RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies offering enhanced performance and positive results more consistently than any standard regulatory information management solution. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.
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  • 2
    Dossier Fleet Maintenance Software
    The fleet maintenance software of choice of over 4,000 private, for-hire and public fleets, Dossier lowers costs and downtime by automating control of your fleet's records, PM scheduling, repair orders and histories, fuel costs and MPG, cost control with cost per mile/hr, parts inventory control w/ auto reordering, work pending and campaign mgmt., budget mgmt., warranty mgmt., tire mgmt., vendor & labor control, license/permit renewals, driver control, fleet benchmarking, VMRS codes & more.
    Starting Price: $1500.00/one-time/user
  • 3
    ViSU

    ViSU

    DDi

    ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control. ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction.
  • 4
    Veeva Vault RIM
    End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps.
  • 5
    RIMTrack

    RIMTrack

    WinWire Technologies

    With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process.
  • 6
    RegDocs Connect
    RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content
  • 7
    Kalypso Accel for RIM
    Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations.
  • 8
    ProcEdge RIMS

    ProcEdge RIMS

    Sarjen Systems Pvt Ltd

    ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.
  • 9
    ClinChoice

    ClinChoice

    ClinChoice

    ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices. ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in regulatory information management system (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in the management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have visibility and tracking of all regulatory information. With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations.
  • 10
    X-doc AI

    X-doc AI

    X-doc AI

    X-doc.ai is the most accurate online AI translator for technical, medical, academic, and regulatory translation across over 100 languages. In recent benchmarks, X-doc AI outperforms Google Translate and DeepL in accuracy by over 7%. Trusted by more than 1,000 global companies, including top names in life sciences and academia, x-doc.ai delivers unmatched precision (99% accuracy) for high-stakes documents such as clinical trial protocols, FDA submissions, regulatory dossiers, scientific publications, patent filings, and product manuals. Recognized as the number one choice for industries that demand accuracy and compliance, X-doc.ai combines batch document processing, OCR translation, context memory, and terminology management to ensure consistency and efficiency across ultra-long, complex files.
    Starting Price: $10/month
  • 11
    LICENSALE

    LICENSALE

    Arazy Group

    All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets.
  • 12
    Essenvia

    Essenvia

    Essenvia

    Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country.
  • 13
    Rimsys

    Rimsys

    Rimsys Regulatory Management Software

    Rimsys is bringing regulatory order to the medtech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys streamlines all regulatory activities including registrations, essential principles, UDI, standards management, and regulatory intelligence in a single, integrated platform.
  • 14
    LifeSphere RIMS
    Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.
  • 15
    BeeCTD

    BeeCTD

    Altamira

    BeeCTD is a full-featured eCTD management solution for pharmaceutical companies and regulatory agencies. Modular architecture and transparent licensing policy allow our users to choose from modules which they want to use – Reader, Compiler, Validator. Full-featured Reader which helps you to get an overview of the entire lifecycle of the dossier containing eCTD and/or NeeS sequences, including baseline submissions while transferring from NeeS to eCTD. Realtime, fast sequence validator fully compliant with eCTD / NeeS technical specification, incl. best practices criteria. The latest version of eCTD validation criteria is always updated, older versions are available. Get your documents compiled into the eCTD-compliant format. Use our eCTD compiler tool as a product, which allows you to compile yourself or as a service - we compile for you on demand.
  • 16
    Ennov Dossier
    The efficient production of PDF publications is an important aspect of a document management operation. Having a single publishing solution that can effectively produce PDF reports and manuals from the source documents contained within your EDMS provides a distinct advantage in terms of flexibility, training and total cost of ownership. Ennov Dossier is complete and scalable dossier management and PDF publishing solution that is suitable for document management operations of all sizes. The software is comprehensive, flexible, intuitive and easy to use. Ennov Dossier provides the ability to build, manage, publish and archive PDF publications using the native capabilities found within Ennov Doc. This eliminates the fragmented and inefficient processes of locating, copying and uploading the documents that you need for your publications, providing a harmonized and seamless dossier publishing solution.
  • 17
    Samarind RMS
    Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™.
  • 18
    Ennov RIM
    Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide.
  • 19
    Dossier

    Dossier

    Dossier Solutions

    Taking competence management as a starting point we improve quality and performance, reduce the risk of errors and ensure compliance. Monitor and manage enterprise-wide compliance in real time and produce reports to demonstrate compliance to satisfy any internal and external audit (e.g. ISO/FDA/GMP) when necessary. Dossier’s customers are always audit ready. Learning does not equal competence at the point of work. By managing competence requirements, Dossier connects learning to organisational objectives. Managers and subject matter experts cannot easily create elearning courses. They can, however, easily create and manage competence plans. This means more relevant, timely and cost effective competence development. Competence requirements make up the DNA of Learning and Development. It’s the fundamental building block of strategic HR and quality management.
  • 20
    Regislate

    Regislate

    Arazy Group

    Everything you need to successfully register your medical device or IVD product in any market around the world and manage your market access license through the product life cycle. REGISLATE® provides users with medical and IVD device-specific at country-specific complete submission file requirements. Users can manage milestones, timelines and estimated and actual completion dates for initial registrations, renewals, amendments and license transfers in real-time. Infographic data and proprietary indicators for clear monitoring and management of each project are available. Utilize collaboration tools for preparation and review of submissions, compliance requirements and documents. Recieve progress reports in real-time for current and future submissions including market access readiness index. REGISLATE® includes GR-MAP registration tracking for both country and product.
  • 21
    GlobalSubmit
    Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.
  • 22
    Ennov Regulatory Suite
    Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning.
  • 23
    Dossiere

    Dossiere

    Dossiere

    Dossiere is a highly secure and feature rich electronic solution that provides access to board, executive and confidential papers. Using an unparalleled document security system you can easily view, annotate, share and collaborate on important documents seamlessly. Dossiere makes organising and distributing meeting agendas simple and efficient. Create meetings, agendas and upload documents for your meeting attendees to review and annotate before the meeting begins. Allow your teams to collaborate and share their comments securely with each other. Documents can be bundled and accessed securely for review pre meetings. Dossiere gives you the control over how to consume and collaborate around the documents, videos and audio files that are delivered to your device. View images, video and audio files at the same time that you are reviewing the relevant documents. Create document annotations or timeline annotations in your audio and video files.
  • 24
    cubeSAFETY

    cubeSAFETY

    CRScube

    cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.
  • 25
    Redica

    Redica

    Redica Systems

    Redica is an intelligence cloud platform designed to support quality and regulatory teams within life sciences organizations. It transforms complex global regulatory data into clear, actionable intelligence that helps teams stay compliant and proactive. The platform unifies regulatory intelligence, inspection findings, and supplier quality insights into a single connected system. By using explainable AI, Redica enables teams to monitor regulatory changes and understand their impact faster. Its inspection intelligence tools help organizations predict and prepare for audits using global benchmarking data. Redica also provides site and supplier intelligence to manage manufacturing and supply chain risks effectively. Overall, the platform shifts teams away from manual data tracking toward faster, insight-driven compliance decisions.
  • 26
    RIMExpert

    RIMExpert

    AMPLEXOR

    RIMExpert™ addresses regulatory planning, tracking and data management by managing the global rollout plans and automating the creation of regulatory applications, activities and medicinal products, RIMExpert™ reduces data entry needs, improving data quality and increasing global oversight and control. Standardize regulatory planning, tracking and registration management processes. Strengthen collaboration between headquarter(s) and affiliates. Create one common place to work in all registration activities. Having one access point to all activities, questions, commitments, correspondence and authorizations for every application. Synchronize efforts for maximum efficiency of enterprise regulatory resources. Control registration activities throughout the lifecycle of the product keeping abreast of timelines and status of commitments and agency questions. Interactive dashboards for actionable regulatory activities and registrations overview.
  • 27
    Wealth-X Diligence
    Wealth-X Diligence provides a unique combination of in-depth intelligence on individuals spanning all levels of wealth for organizations looking to meet regulatory or best practice requirements and mitigate reputational and commercial risk. Our expert global research team helps you close the gaps in your compliance approach, including a comprehensive analysis of a client’s net worth and source of wealth, and identifying whether it has been accumulated legitimately. With increasing regulation and trends toward greater transparency, understanding the source of wealth is a cornerstone of due diligence. Organizations should not only be concerned with non-compliance and regulatory penalties but by the costs of reputational damage. The Wealth-X Diligence dossier helps to avoid information overload during the diligence process by providing concise and relevant intelligence and removing unnecessary noise.
  • 28
    Ennov Doc
    Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries
  • 29
    IQVIA RIM Smart
    Streamline your regulatory processes with our new, end-to-end regulatory information management system, IQVIA RIM Smart. Free your team from labor-intensive maintenance to focus on delivering valuable products to market. RIM Smart is the modern regulatory information management solution built to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost. Delivered securely in the cloud, IQVIA RIM Smart provides interconnected, comprehensive and intelligent management of the entire regulatory process. IQVIA safety and quality platform integration will heighten performance and enhance flexibility. Automate manual processes and increase connectivity for improved efficiency, cost savings, and better coordination and cross-enterprise visibility.
  • 30
    Dow Jones Risk & Compliance

    Dow Jones Risk & Compliance

    Dow Jones Risk & Compliance

    Dow Jones Risk & Compliance is a global provider of best-in-class risk data, web-based software applications and scalable due diligence services that help organizations manage risk and meet regulatory requirements related to financial crime, third-party risk management, sanctions and international trade. Built on the legacy of one of the world’s most trusted newsrooms, Dow Jones Risk & Compliance combines the expertise of a multilingual research team with industry-leading data scientists and technologists to provide actionable content structured specifically for compliance needs. Our solutions were developed in partnership with top legal and political advisors — including former regulators — to help our clients maintain consistency across global business units and teams.
  • 31
    PhlexRIM

    PhlexRIM

    Phlexglobal

    PhlexRIM will dramatically improve compliance with efficient and effective real-time access to your global registration information. PhlexRIM 2.0 contains a library of pre-configured automation assistants, or “bots,” as well as built-in regulatory use cases based on industry best practices. Utilizing an intuitive drag-and-drop design tool, regulatory teams can automate their business processes without programming knowledge or IT support. Manage the lifecycle of pharmaceutical product registration activities. Get extensive status information and use the alert management which is included in all workflows. Illustrate reports using standard reports or design your own reports. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.
  • 32
    Confluence

    Confluence

    Confluence Technologies

    Confluence Technologies is a global leader in data-driven investment management solutions, helping clients optimize efficiency and control across regulatory, analytics, and investor communications. Serving over 1,000 clients in 40 countries, including top asset managers and service providers, Confluence delivers products and services designed to streamline investment monitoring, risk management, and regulatory compliance.
  • 33
    Freya

    Freya

    Freyr Solutions

    Freya is an AI-powered chatbot designed to streamline the process of navigating complex global regulatory frameworks. It enables users to ask direct questions and receive prompt, accurate, and verified answers based on a comprehensive database of over 40,000 regulations across 150+ markets. Freya offers real-time access to regulatory updates, translations, and document summaries, making it easier for regulatory affairs teams to manage compliance. The platform is powered by over a decade of regulatory intelligence and integrates seamlessly with your existing systems, providing actionable insights and helping companies save time and reduce compliance risks.
  • 34
    RegMind

    RegMind

    RegMind

    RegMind is a smart regulatory intelligence platform built for the banking, finance, and insurance industries. It maintains a real-time inventory of global, European, and national regulations, sourcing data from authorities such as FATF, EU Commission, ECB, AMF, and more. With automated comparison tools, RegMind highlights changes between versions of texts, tracks parliamentary debates, and maps the full evolution of laws and directives. Users can set custom alerts, follow related guidelines and Q&As, and leverage a 360° view that shows how laws impact specific codes and articles. Teams can collaborate through shared folders and integrate research directly into Microsoft Teams. Its Smart Sanctions Analyser® module provides deep insights into sanctions from French and European regulators, helping organizations avoid compliance risks and penalties.
  • 35
    Cappitech

    Cappitech

    S&P Global Market Intelligence

    Cappitech is a cloud-based regulatory reporting and business intelligence platform that automates the collection, validation, enrichment, reconciliation, and submission of trade and transaction reporting data across multiple global regimes and authorities, helping firms comply with complex requirements such as EMIR, MiFID/MiFIR, SFTR, and other jurisdiction-specific rules from a single unified hub with secure, scalable architecture. It connects to data sources via APIs, file uploads, database access, or standard formats, ensures accurate pairing and matching of identifiers and reportable fields, identifies exceptions before they reach regulators, and monitors submissions through an intuitive dashboard that provides transparency into workflows, KPIs, and compliance status while lowering the total cost of ownership through automation and quick onboarding.
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    Nexis Dossier

    Nexis Dossier

    LexisNexis

    Gain deeper insights into key players in your industry with access to comprehensive data on companies and executives. Nexis® Dossier helps you quickly capture critical business intelligence. Identify your competitors’ strengths, weakness, opportunities and threats with built-in SWOT analyses. Quickly generate reports, so you can spend less time gathering insights and more time acting on them. Stay on top of what’s happening across your industry, including fast access to up-to-date information on M&A activity—from initial announcement to post-merger reconciliations. Access information on 75 million executives from one convenient platform. Easily generate a prospect list based on criteria you choose, including industry codes, sales revenue, number of employees and more. Whether you’re researching competitors or preparing a pitch for a prospective client, Nexis Dossier lets you create custom company reports with financial details, analysts’ insights, and other competitive insights.
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    Accruent Meridian
    Keep all your documents and drawings in one place with our top-performing enterprise document management software. Meridian provides a single source of truth, configurable workflows to streamline collaboration with all internal departments and ensures every document change is versioned and audited to demonstrate regulatory compliance. Engineering document management is the process of effectively searching for, finding and managing the complex engineering documents – including CAD files, drawings, designs, technical documents and communication documents, that exist in AEC organizations (Architecture, Engineering & Construction). Effective engineering document management can often be difficult for businesses in these industries. Meridian’s document management system for engineering projects can resolve these concerns. Meridian can centralize an organization’s relevant documents and drawings while automating key processes.
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    FurtherAI

    FurtherAI

    FurtherAI

    FurtherAI is a domain-specific AI workspace designed for commercial insurance operations, automating repetitive tasks across submission intake, underwriting audits, policy comparisons, and claims workflows. It offers an AI Assistant that can read, write, compare, classify, summarize, and reason about insurance documents and data, integrated into modular workflows that mirror insurance processes. The platform is fine-tuned for policy language, underwriting rules, and regulatory norms and supports seamless integration with over 100 enterprise systems. Its architecture is modular and adaptable, whether orchestration of submissions, audits, or policy management, and it combines multiple large language models to maximize task accuracy. FurtherAI also features a human-AI interface to allow collaboration and oversight, ensuring higher precision in sensitive operations.
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    AmpleLogic Regulatory Information Management System
    AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.
  • 40
    Infosys Regulated Document Management
    Regulatory functions hinge on high-cost contributors across a variety of regulatory content. A cloud-based offering like Infosys regulated document management platform is the perfect solution to this problem. Externalization, collaborative authoring and editing. Simplify governance, processes, and implement consumption-based commercial model; provide support for audit trails. Create custom workflows, and provide support for versioning; implement a proven solution with 99.95% guaranteed uptime in production. Our solution enabled business users to search documents from a vast repository within 3/4 seconds. The new system also offered users unlimited on-demand storage. The DMS uses Google application programming interfaces (APIs) to reduce operational and maintenance costs. The company’s overheads are limited to API usage and storage space.
  • 41
    DXC RIM
    DXC RIM platform manages regulatory affairs content, data, and workflows in one central location, helping teams accelerate innovation and reduce time to market. The sensitive nature of regulatory affairs (RA) content demands a unified platform to handle regulatory data and workflows. Teams need simple, always-ready access to all relevant data. They also require an intuitive, customizable user interface that is easy to navigate. Collaborative tools and configurable reporting are crucial for success, but legacy technology can frustrate teams and slow processes. Achieving compliance is a struggle. Collecting data and documenting processes is time-consuming. Problems are compounded when life sciences organizations run fragmented legacy systems using disparate technologies. In some cases, they need to resort to spreadsheets to manage key operational processes. Bringing products to market and managing RA requires a centralized, enterprise-grade solution.
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    Beaconcure

    Beaconcure

    Beaconcure

    Intelligent clinical data analysis. Accelerate and de-risk regulatory approvals with our automated analytics and validation platform. The clinical data analytics software unlike no other improve data quality & de-risk your submission. Automate your manual quality process, Avoid QC rerun, Eliminate data duplication or inconsistencies, Ensure data traceability, Transparent quality process. Accelerate time to market & generate revenue earlier. reduce data validation time. free up resources, reduce cost. Accelerate regulatory approval. The need for accurate clinical data validation and high-quality data output has never been more urgent. Verify manages and analyzes clinical data to mitigate risk and expedite approval of a new drug and vaccine. Ensure quality, speed & success.
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    Cruxi

    Cruxi

    Cruxi

    Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.
    Starting Price: Credit-based system
  • 44
    Patentics

    Patentics

    Patentics

    Patentics is an AI-driven patent intelligence platform that combines third-generation semantic search, high-fidelity translation, deep data processing, and automated analysis to help users uncover, evaluate, and visualize global patent information. Leveraging a model trained on tens of millions of data points, Patentics' semantic engine interprets patent text, expands related expressions, auto-classifies IPC codes, and surfaces the most relevant prior art, even identifying documents that threaten novelty or inventiveness. It ingests and normalizes data from 160+ national and regional patent offices and over 130 analytical fields, enriching dossiers with family, citation, transaction, and legal-status metadata. Native Chinese-to-English and English-to-Chinese neural translation lets users search and browse foreign patents in their preferred language. Built-in operators, visual query flows, and clustering tools support multi-dimensional filtering, grouping, and mapping.
  • 45
    QEdge

    QEdge

    Sarjen Systems Pvt Ltd

    Sarjen's QEdge stands as a robust, risk-based enterprise Quality Management System, meticulously designed for the pharmaceutical manufacturing and broader life sciences industries. This comprehensive solution adeptly streamlines crucial quality processes, including Change Control, Deviation management, CAPA, efficient Document Management, and automated Training with SCORM-based eLearning. QEdge ensures stringent and full compliance with major regulatory standards such as FDA, EU-GMP, and ICH guidelines. By fostering operational excellence, maintaining impeccable data integrity, and guaranteeing audit-readiness in complex GxP environments, QEdge significantly enhances overall quality management. It provides essential process control and simplified vendor qualification, driving efficiency and superior quality across all operations.
  • 46
    Process XE

    Process XE

    Sarjen Systems Pvt Ltd

    Process XE by Sarjen System's is a Manufacturing Process Automation solution, serving as a comprehensive Manufacturing Execution System (MES) for pharma manufacturing. It significantly enhances overall efficiency, visibility, and control across the entire shop floor. This powerful system streamlines critical operations including batch manufacturing, packaging, and equipment management. Process XE ensures real-time data capture, adhering to ALCOA+ principles and 21 CFR Part 11 regulatory compliance. Key features encompass electronic batch records (eBMR/eBPR), robust weighing and dispensing management (WDMS), and comprehensive digital logbooks. It enables paperless, audit-ready manufacturing, greatly improving process efficiency, ensuring end-to-end data integrity, and complete traceability for optimal pharmaceutical operations.
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    Humanwave

    Humanwave

    Humanwave

    Humanwave is the HR software for the SME manager and his team. With the humanwave app, it is possible to request leave, report illness, enter expense claims, see payslips, view your planning and check your own dossier. Arrange and manage your HR administration in one place. No more loose Excel sheets, notes and notes. Add a new employee, including all documents and the digitally signing contract. Employees do this themselves, so the leave is always current. You can immediately see who are and who are not.
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    Impurity Profiling Suite
    Predict genotoxic & carcinogenic endpoints of impurities and degradants to meet ICH M7 guidelines. Impurity Profiling Suite can be used as part of your ICH M7 workflow—to help prepare regulatory submissions and remain compliant.
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    PharmaPendium
    PharmaPendium is a comprehensive resource that provides access to FDA and EMA drug approval documents, including pharmacokinetic, pharmacodynamic, and safety profiles. It offers detailed information on drug-drug interactions, adverse effects, and clinical study outcomes, facilitating informed decision-making in drug development and regulatory submissions. The platform's extensive data supports researchers and healthcare professionals in evaluating drug efficacy and safety, contributing to the advancement of pharmaceutical research and patient care. Find information about previous regulatory submissions and profit from precedents to predict agencies’ requirements. Seamlessly move from table view to interactive charts, graphs, and visual aids to easily interrogate and interpret data. Find information by adverse events (MedDRA), targets, indications, drug,s and endpoints using normalized data. Result pages bridge the preclinical to clinical divide.
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    Jade ThirdEye

    Jade ThirdEye

    Jade ThirdEye

    We’re on a mission to help businesses fight financial crime. We create tailor-made tech solutions that give our clients the tools to stop financial crime before it happens. With flexible software and local support, we give you more time for what matters – protecting your customers. ---- The Jade ThirdEye platform consists of: CUSTOMER SCREENING Protect your business from high-risk individuals with PEP and sanction screening, bolstered by intelligent matching against global watchlists. TRANSACTION MONITORING Flexible transaction monitoring that helps you act before risk becomes reality. CASE MANAGEMENT Turn complex investigations into clear decisions with streamlined case management tools. SUSPICIOUS ACTIVITY REPORTING Streamline suspicious activity reporting. Faster submissions, higher quality, complete oversight. MANDATORY REGULATORY REPORTING Streamline high-volume regulatory reporting with clever automation and full audit trails.