Alternatives to Rimsys
Compare Rimsys alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Rimsys in 2026. Compare features, ratings, user reviews, pricing, and more from Rimsys competitors and alternatives in order to make an informed decision for your business.
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Predict360
360factors
Predict360 is an integrated risk and compliance management software platform for financial and insurance organizations. It integrates risk and compliance processes and industry best practices content into a single platform that streamlines regulatory compliance, improves efficiency, predicts risk, and provides best-in-class business intelligence reporting. Predict360 includes the following Risk Management applications: Enterprise Risk Management (ERM), Risk Management and Assessments, Risk Insights, Issues Management, Peer Insights, Third-Party Risk Management, and Quarterly Certifications and Attestations. Compliance applications are: Compliance Management, Compliance Monitoring & Testing, Complaints Management, Regulatory Change Management, Regulatory Examination and Findings Management, Policy & Procedure Management, and more. 360factors also offers Lumify360 - a KPI and KRI predictive analytics platform that enriches data, predicts performance, and works alongside any GRC. -
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RegDesk
RegDesk
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. 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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C2P
Compliance and Risks
Compliance & Risks works with the world’s leading brands including Dyson, Samsung, Miele, Kodak and Stryker, to unlock market access by simplifying the Product Compliance and ESG Compliance process. We have 3 key elements to our offering: 1. C2P, Enterprise technology solution to help improve productivity & efficiency 2. Most comprehensive regulatory content in the market with over 40+ topics covering 20+ industries and 195 countries worldwide 3. Team of 50+ Subject Matter Experts on hand to help answer any regulatory queries you need We help you monitor the relevant regulations and standards for your products and business, assess their relevance and impact, and prove ESG and product compliance to stay in market and grow your business successfully. With over 20 years of experience working with the world’s biggest brands we have an unparalleled track record of helping companies manage their compliance risks more effectively than ever before. -
4
SAI360
SAI360
The most powerful, agile approach to risk management. The decisions you make today can help mitigate the risks you may encounter tomorrow. SAI360 is cloud-first software and modern ethics and compliance learning content designed to help your organization effectively navigate risk with a flexible, agile approach. Intelligent solutions, global expertise all in one award-winning platform. Solution configurability, extensible data model with configurable UI/forms, fields, relationships to extend solutions. Process modeling, easily modify or create new processes to automate and streamline risk, compliance, and audit activities. Data visualization and analysis, many out of the box and easy to configure dashboards to visualize and analyze data. Learning and best practice content – preloaded frameworks, control libraries, and regulatory content along with values-based ethics and compliance learning content. System integration – Integration framework with APIs and other protocols. -
5
meddevo
dytab GmbH
Discover a new way to manage the technical documentation of your medical devices with meddevo, a cloud-based tool crafted for the medtech industry. Seamless Digitization: Completely transform and automate your regulatory affairs process, ensuring you're always aligned with international standards, including EU-MDR, EU-IVDR, and ANVISA. User-friendly Experience: Using meddevo is as straightforward as filling out an online form. No steep learning curve, ensuring a smooth onboarding for your team. Effortless Integration: Import and export data with ease, making integration into your current systems straightforward. Top-tier Security: Hosted on the robust AWS platform, meddevo prioritizes your data's security. Activate 2-Factor Authentication (2FA) for an added layer of protection. Unrestricted Trial: Experience all that meddevo offers during the free trial, ensuring a comprehensive understanding of its capabilities.Starting Price: 249€/User -
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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. -
7
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. -
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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. -
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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. -
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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.Starting Price: $300 -
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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. -
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Veeva Vault RIM
Veeva
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. -
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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. -
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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. -
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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. -
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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. -
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Corlytics
Corlytics
Corlytics is a global leader in regulatory risk intelligence, helping financial institutions, regulators, and advisors manage compliance through data-driven insights. Headquartered in Dublin, Ireland, with offices in London, New York City, Boston, and Sydney, the company provides regulatory monitoring, taxonomy mapping, and advisory services to streamline compliance processes. By combining legal and regulatory expertise with advanced data analytics, Corlytics delivers actionable intelligence that enables organizations to navigate complex regulatory landscapes efficiently. With a strong focus on innovation, Corlytics continues to develop cutting-edge solutions that support financial firms in mitigating risk and ensuring regulatory compliance. -
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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. -
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KnowledgeNET
Sarjen Systems
Sarjen's global dossier publishing software is a platform designed to simplify and automate the management and submission of regulatory dossiers. It streamlines the regulatory submission process by automating region-specific and product-specific workflows, which enhances consistency, efficiency, and accuracy. This automation helps to accelerate the creation, validation, and submission of dossiers, reducing manual errors and compliance issues. The solution is built to improve operational efficiency, maintain data consistency, and ensure documentation is audit-ready. By doing so, it saves time and facilitates faster regulatory approvals, ultimately helping to ensure submissions are compliant with various global requirements.Starting Price: $200 -
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Kalypso Accel for RIM
Kalypso
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. -
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LifeSphere RIMS
ArisGlobal
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. -
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Finreg-E
Finreg-E
Revolutionizing the processes around identification and understanding of global financial regulatory rules through technology to make Financial Regulation Easy. AI driven regulatory compliance and change management to make Financial Regulation Easy. Finreg-E harnesses the power of machine learning and artificial intelligence to automatically extract key actions under regulatory rules, connect them to internal controls and deliver intuitive workflows to fill gaps in compliance. Finreg-E’s provides a unique regulatory compliance and change management application that uses innovative technology to bring automation and efficiencies in the identification, analysis and compliance with global financial regulatory rules. Leveraging technologies such as artificial intelligence, natural language processing, topic modelling and deep learning, Finreg-E dynamically connects regulatory requirements to internal policies, procedures and controls. -
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RegDocs Connect
Montrium
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 -
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CUBE RegPlatform
CUBE
CUBE RegPlatform is our trusted, world-beating SaaS platform, providing the world’s most comprehensive source of classified, meaningful regulatory intelligence for large global financial organizations. Our RegPlatform product combines industry leading technology with expert validated insights to present a future proof, constantly up-to-date service that simplifies the complexities of multi-jurisdictional regulatory compliance. RegPlatform comprises a series of bespoke modules, allowing you to tailor our product to suit your global business and compliance needs. If you’re a large financial organization looking to streamline regulatory compliance on a global scale, then RegPlatform is the trusted partner for your compliance team. Our philosophy is founded on the Three R’s: to deliver real-time, relevant regulatory intelligence that mitigates compliance risk. We do this by leveraging leading techniques in artificial intelligence, from machine learning to natural language processing. -
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Lawrbit
Lawrbit Global Compliance Network
Regulatory Risks are amongst the Top 3 Business Risks globally as there are multiple Laws (Central, State & Municipal level) applicable to each business. Laws are frequently changing, are complex, and involves multiple stakeholders (internal/external) to manage. The Board needs to have oversight of their compliance and regulatory risks across the enterprise, which means understanding which Regulatory obligations map to which business processes, policies & controls. Offered as SaaS, GCMS helps businesses create a centralized framework to proactively monitor Regulatory Risks across an extensive range of Compliance obligations from all applicable Laws; enabling the Board to efficiently manage control across geography, functional, and industry mandates. Build on Twin Software Architecture, GCMS integrates Tech with Regulatory Intelligence & Updates for 1,000s of Laws, Regulations from 70+ Countries. GCMS simplifies understanding and adhering to all Compliance obligations. -
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DXC RIM
DXC
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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Vixio
Vixio
Vixio is a regulatory-intelligence platform that gives compliance and legal teams real-time clarity and control over changing rules across more than 200 jurisdictions and 1,400 regulatory authorities. It combines expert human analysis with AI-driven tools, including horizon scanning, a regulatory library, a global data hub, market assessments, and a custom report builder, to monitor legislative and regulatory developments, compare requirements across regions, and surface governance risks. In 2025, Vixio expanded with Vixio Workspace, a workflow and compliance-management add-on that links regulatory change intelligence to actionable tasks; compliance teams can create checklists, assign tasks, collaborate internally, track progress in dashboards, manage attestation records, upload evidence, and maintain a full audit trail, eliminating reliance on scattered spreadsheets, emails, or disjointed tools. -
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Thomson Reuters Regulatory Intelligence
Thomson Reuters
The banking, financial services and insurance sectors continue to experience unprecedented volumes of regulatory change and complexity. Thomson Reuters Regulatory Intelligence is a single solution that empowers compliance professionals to make well-informed decisions to confidently manage regulatory risk, while providing the tools to make proactive decisions and action change within their organizations. -
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Ennov RIM
Ennov
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. -
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IQVIA RIM Smart
IQVIA
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. -
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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. -
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RegPass
RegPass
RegPass™ is the compliance co-pilot built to 10× your team’s impact. From horizon scanning to assurance, RegPass connects every stage of the regulatory change lifecycle: Horizon Scanning → Rules Inventory → Policies & Controls → Regulatory Policy Advisor. Stay ahead with comprehensive global coverage and intelligent Business Profiles that filter alerts to what’s truly relevant. Our enriched Rules Inventory consolidates overlapping obligations into canonical ones for clarity and traceability. AI sits at the heart of RegPass, extracting, prioritizing, and mapping obligations to your policies and controls with clear rationale. Every suggestion is explained, auditable, and ready for approval. Built by the experts at Braithwate, RegPass encodes decades of regulatory change experience into a powerful knowledge graph. Open, extensible, and transparent by default, RegPass delivers end-to-end traceability, helping teams work faster, reduce risk, and strengthen compliance. -
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Regology
Regology
First of its kind - we have codified human legal intelligence, scaled millions of laws, established billions of links between them, and mapped them to compliance objects. Let Regology identify the impact of regulatory changes and save hundreds of hours. Smart law library that keeps your regulatory content up-to-date. All relevant updates and actionable content at your fingertips. Deep compliance functionality connected to your smart library. Intelligence that automatically tracks progression through the law making process. Regology's standard citation lets the AI Engine track interconnected legal systems within and across jurisdictions. Definitions, requirements, and scope of applicability improves readability and understanding of the text. Multiple jurisdictions and agencies combined with intelligence leads to a new era of research and compliance. -
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RegRadar
RegRadar
RegRadar uses advanced technology to help you sanitize and manage regulatory changes and response. Powerful dashboard with responsive functionality that can be adapted to any device. Personalize RegStream to search and browse through hundreds of regulatory publications. Save and track regulatory publications, share bookmarks, and identify trending topics. Demonstrate regulatory response efforts and keep track of usage. Get the grasp of regulatory publication by reviewing the cognitive analytics results. Eliminate the language barrier by producing all publications in English. Manage and monitor review status over specific publications. RegRadar leverages artificial intelligence technologies to give you instant access to information that matters, supporting your decision-making processes and helping you address emerging topics. -
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OneTrust Tech Risk and Compliance
OneTrust
Scale your risk and security functions so you can operate through challenges with confidence. The global threat landscape continues to evolve each day, bringing new and unexpected risks to people and organizations. The OneTrust Tech Risk and Compliance brings resiliency to your organization and supply chain in the face of continuous cyber threats, global crises, and more – so you can operate with confidence. Manage increasingly complex regulations, security frameworks, and compliance needs with a unified platform for prioritizing and managing risk. Gain regulatory intelligence and manage first- or third-party risk based on your chosen methodology. Centralize policy development with embedded business intelligence and collaboration capabilities. Automate evidence collection and manage GRC tasks across the business with ease. -
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Thomson Reuters Compliance Learning
Thomson Reuters
Discover customized online training and provide employees with the tools and knowledge to build a culture of compliance. Employing instructional design techniques optimized for risk and compliance training our courses are driven by practical examples and interactive scenarios. They’re tailored to support your business at a country, regional, and global level supported in over 25 languages and with full audit trail capabilities. Content for our course library is powered by world-leading regulatory intelligence and courses are updated in response to the latest regulatory and legislative changes. Our courses are fully customizable and scalable to fit the exact learning objectives set by your business. We offer a range of options and courses can be built from scratch to fit your business requirements on any governance, risk and compliance topics. -
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Obsidian Monitoring Advisory
Obsidian Technologies Sarl
Obsidian is a specialized monitoring platform that delivers actionable regulatory intelligence to compliance and strategy teams. By bypassing third-party aggregators, we provide a direct pipeline to official government agencies and regulatory bodies worldwide. Core Functionality 24/7 Global Monitoring: Our infrastructure continuously scans official sources (e.g., FDA, Légifrance) to deliver updates the moment they are published. 100% Official Data: Every data point—from legislative acts to technical pharmaceutical filings—comes directly from the source to ensure zero noise and maximum reliability. Industry-Specific Feeds: Tailored intelligence across critical sectors, including: Chemicals & PFAS: Tracking evolving environmental restrictions. ESG & CSRD: Monitoring sustainability and corporate reporting mandates. Life Sciences: Real-time updates on pharmaceutical compliance and technical filings.Starting Price: 59 CHF / month / user -
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RAMS
Emergo by UL
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance. -
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CoComply
CoComply
CoComply’s Certification Platform provides a top-down view of data and AI criticality, guiding organizations through a four-phase process to achieve governance, certification, and monetization readiness for their data and AI assets. Designed to streamline Data and AI Governance, the platform helps organizations organize, manage, and certify their assets in alignment with regulatory standards and compliance requirements. The platform is powered by two key modules: 1) Regulatory Intelligence 2) Certification Management CoComply provides organizations with a systematic pathway to achieve compliance, audit readiness, and certification of their data and AI assets. Since 2008 more than 200 data and AI use cases have been certified for compliance, risk and monetization by using our certification framework.Starting Price: $999 -
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Capnovum
Capnovum
Capnovum’s cognitive compliance management platform provides an up-to-date repository of regulations, obligations and regulatory news; that lets regulated entities manage compliance and resource utilisation across jurisdictions. Artificial intelligence (AI) is leveraged to understand and identify synergies between regulations, assess the footprint of business models and impact of regulatory updates. Capnovum eliminates manual work and external spend that traditionally go into producing and disseminating static reports. Reducing cost, improving timeliness and quality. By combining automation and AI, critical information and insights are available on demand and flow seamlessly to all key stakeholders within your organisation. We recognise that distraction and pressure on our time has become the new normal and cutting through that noise to provide you with the information you need, quickly and concisely is what matters. -
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Samarind RMS
Instem
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™. -
42
Ennov Regulatory Suite
Ennov
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. -
43
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. -
44
crlHorizon
crlHorizon
Break down your regulatory and contractual obligations into discrete actions that can be assigned and monitored through interactive dashboards. Drill down into each business area and identify where you are exposed, then categorize and mitigate potential risks. Manage IT system risk with user access reviews and contract renewal management. Set up your corporate structure and track all your legal and corporate-level correspondence with regulators. Manage your licence requirements, and statutory and regulatory reporting from one system. Keep a track of all your incidents, complaints and breaches. Use the data to highlight key business risks and implement change management. Validate and check that all the controls you have in place actually work through compliance assurance checklists. Understand your obligations and identify the scope of work you need to perform as part of your organizations compliance framework.Starting Price: $10 per month -
45
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.
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46
DataGrail
DataGrail
DataGrail is a complete, AI-powered privacy automation platform for privacy, legal, and security teams at the world’s leading brands. Brands like Bed Bath & Beyond, Sportsman’s Warehouse, Carvana and more choose DataGrail for: → Enterprise-grade consent management → AI-powered data mapping and risk intelligence → Deep integration and end-to-end privacy automation → Industry-best support and privacy expertise Founded in 2018 and now headquartered in San Francisco, CA, DataGrail helps brands eliminate privacy risk, build customer trust, and ensure compliance with ever-evolving regulatory demands. -
47
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.
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Complinity
COMPLINITY
Complinity is a comprehensive Cloud-based Compliance Management System that Tracks and Monitors statutory, regulatory, central & state, secretarial and legal compliances within a company. It helps businesses manage all their compliance documentation, activities, conduct audits, track and resolve compliance issues on the cloud. Complinity secures your business and makes operational processes more efficient. Complinity is an amalgamation of the words Compliance and Infinity. What it essentially is, an Infinite Compliance System. We relate the system to infinity, since at the core of this cloud software, lies an auto-scheduler which creates compliances for an organization till an infinite amount of time and also because it has no limitations in terms of users, locations, departments, acts and ability to create compliances. An intelligent scheduler automatically creates compliance schedules for a year, making sure that no manual intervention is required once the system is implemented. -
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Accruent Meridian
Accruent
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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Totum Compliance
Totum Compliance
No matter what business you’re in, companies, governments and communities around the world are grappling with an evolving regulatory landscape, whether it’s cross-border data privacy concerns or balancing economic growth against the global shift to a low-carbon future. With that comes regulatory change and increased governmental and public scrutiny of how companies are conducting their activities and meeting regulatory compliance requirements. Totum specialises in cloud-based compliance management software. Originally developed for the highly-regulated oil and gas industry, Totum Compliance provides a holistic and automated approach to managing global and local compliance requirements, by delivering timely and relevant information to operational teams. We create a single source of truth, enabling companies to efficiently manage the vast and complex range of obligations they must meet to maintain their legal and social license to operate, anywhere in the world.
