Alternatives to Ennov RIM
Compare Ennov RIM alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Ennov RIM in 2025. Compare features, ratings, user reviews, pricing, and more from Ennov RIM competitors and alternatives in order to make an informed decision for your business.
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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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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. -
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Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency -
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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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Ennov CTMS
Ennov
Ennov CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, to make better decisions, to ensure compliance, to select investigators well, to monitor patient recruitment and to manage finances. Ennov CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and organizations (hospitals, competent authorities, CROs, suppliers). Ennov CTMS provides functions for tracking patients, patient visits, EDC data, activities, queries, deviations, adverse events, drug supply, monitoring visits and finances. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible. - Comprehensive CTMS software - Integrated with Ennov Clinical Data Management - Clear visibility into investigational sites - Integrated workflow -
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Ennov Process
Ennov
The Ennov platform includes its own workflow engine that provides advanced capabilities. Workflows are used in Ennov Training, Ennov eTMF and Ennov RIM. They allow control of the sequencing of tasks and data modification while providing visibility across the organization. Workflows are entirely configurable by functional administrators (through a graphical interface). Coherence checks are performed whenever you save modifications in order to make sure they do not cause inconsistencies. Thus, Ennov guarantees workflows are coherent and reliable. Each Ennov workflow is associated with a configurable form. Data entry is facilitated using dynamic sections that are displayed – or not – depending on previously entered field values (for example: the type of Incident). The connected user enters free text, selects values in picklists and adds additional files when needed. An electronic signature can also be required to complete a workflow step. -
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EnNovate
Enqura
Enhancing the user experience through mobile and web applications that provide seamless access to financial services. EnNovate offer interactive access to financial services via modern mobile and internet applications, with a focus on exceptional user experience. Unlike custom-built solutions, EnNovate is a mature product that accelerates digital transformation while reducing time-to-market by up to 50%, providing a competitive advantage. EnNovate provides a robust business layer, enabling seamless integration and management of various digital channels, enhancing operational efficiency and flexibility. -
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Ennov Training
Ennov
Managing the training requirements required for compliance with your quality standards can be labor intensive and time consuming work. A fully integrated electronic Learning Management System can greatly simplify the planning, execution and management of your training program through automation and the elimination of paperwork and manual administrative tasks. Ennov Training is a purpose-built eLearning solution that is part of the Ennov Compliance Platform. It allows Quality, Human Resources and Department Managers to build flexible training curricula, monitor compliance, evaluate staff proficiency and maintain inspection-ready training records without a heavy administrative burden. Ennov Training helps you stay flexible, audit-ready and compliant while ensuring all staff members have the requisite knowledge to perform their duties at an optimal level. -
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Ennov Dossier
Ennov
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. -
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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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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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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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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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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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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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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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Ennov Doc
Ennov
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 -
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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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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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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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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. -
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Ennov's Pharmacovigilance Suite is an end-to-end solution for collecting, managing, assessing, and reporting human and veterinary adverse events within a unified database. The suite offers advanced signal detection and data analysis tools, ensuring compliance with global regulatory requirements. Key features include efficient case intake and triage with optimized user interfaces for data entry, flexible case input forms, and searchable vocabulary lists. The system supports both paper and electronic reporting formats, including CIOMS, MedWatch 3500s, and ICH E2B standards (R2 and R3 formats). For signal detection and management, it provides comprehensive data querying, powerful analysis capabilities, and the calculation of key statistical measures such as PRR, ROR, and MGPS. The platform is 100% web-based, user-friendly, and designed to comply with 21 CFR Part 11, ensuring data integrity and security.
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OpenText for Life Sciences
OpenText
OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts. -
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EXTEDOpulse
EXTEDO
EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individually or gain additional value by using them together based on your requirements. Developing pharmaceutical products can be a multi-faceted process, involving input and efforts from across an organization. The complexities of operating within a highly regulated industry only further compound the challenges that a life science organization faces with every release. Having our finger on the pulse of the life sciences anatomy allows us to provide you with great synergy, connection and innovation for effortless compliance. EXTEDOpulse has been designed with these aspects in mind to help you connecting the dots throughout the entire lifecycle of pharmaceutical products. EXTEDO understands the complexities of the regulated pharmaceutical product journey. -
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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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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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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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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™. -
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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. -
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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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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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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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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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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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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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ComplianceAuthor
Glemser Technologies
Glemser provides IT solutions for regulated industries with a focus on global life sciences and the ecosystem that improves patient outcomes. ComplianceAuthor makes it seamless for life science companies to manage global product labeling, provide affordable IDMP and reduce compliance risk. ComplianceAuthor for Global Labeling helps life science regulatory professionals manage, scale, and streamline global product labeling and compliance through artificial intelligence, structured content, and natural language generation. Artificial intelligence and machine learning to find, index and derive knowledge needed to recommend your next best course of action. Our workflow overlays provide innovation for process standardization, resulting in components that are compliant and controlled. Natural language generation enables you to adopt operational efficiencies and smarter automation. -
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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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FactoryTalk PharmaSuite
Rockwell Automation
FactoryTalk® PharmaSuite is the leading MES solution developed specifically for the Life Sciences industry. It provides role-based optimization of each stage of the recipe life cycle and drives time to results for all users. Its open-content architecture paired with an intelligent upgrade engine provides a powerful system for growth in both batch and discrete processing. Our FactoryTalk PharmaSuite MES provides value-based applications to help you adhere to regulatory compliance guidelines. MES also helps you achieve operational excellence, increase the effectiveness of your supply chain, and meet your sustainability goals. PharmaSuite MES provides production operations management to help you meet regulatory compliance, achieve operational excellence, increase supply chain effectiveness, and meet your goals. Optimize production, speed time-to-market, and ease compliance with a modern MES. -
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Datatrak
Datatrak International, Inc.
Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak’s unified eClinical solutions and related services help improve cost and time efficiencies for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via Datatrak’s Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. Our commitment is to empower workgroup teams with role-based access to version-controlled file management, calendar events, tasks and contacts, all built within our eClinical applications including EDC, CTMS, reporting, data analytics and business intelligence. -
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Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
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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. -
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CINCO
Cinco
A web based software that uses Quality Risk Management to organize, analyze and trace Quality information directly to the specific risk it represents to the patient and drug product. Why Us? CINCO, a risk-based quality management software for the Life Sciences Industry. It provides paperless traceability of every critical to quality aspect of a drug or medical device to enable transparent quality decisions at every moment. Why Risk Management? Quality Risk Management is methodology that provides an objective approach into identifying and mitigating the risks of a drug or medical device manufacturing process. It is currently required by most regulatory agencies. However, the paper-based approach the Life Sciences Industry currently uses its ineffective in managing the significant and valuable risk data. It is prone to errors, introduces too much friction to the users and ends up not adding the potential value to the operations. On-demand access to what is critical to the product qua -
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Flatiron Horizon
Flatiron
Flatiron Health's Evidence Solutions offer a flexible approach to generating both prospective and retrospective real-world evidence, empowering life sciences companies to achieve their oncology research goals more efficiently. Central to these solutions is Flatiron Horizon, which integrates a vast repository of over 5 million de-identified patient records and 1.5 billion data points, advanced curation methods, and disease-specific machine-learning models. This platform supports various stages of the biopharma lifecycle, including discovery, clinical study design, regulatory submissions, and post-marketing commitments. Flatiron's services encompass real-world data configurations tailored to specific oncology needs, prospective evidence generation through low-interventional studies, protocol optimization, patient identification, and seamless EHR-to-EDC data transfer via Flatiron Clinical Pipe. -
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Pepper Flow
Vodori
Pepper Flow’s unique features are built specifically to help life science companies streamline how marketing, medical, legal, and regulatory professionals work together. As a marketer, you need tools that allow you to move fast and keep things simple during advertising and promotional reviews. Get your critical campaigns and content to market to support your organization’s strategic initiatives. Maximize productivity by collaborating in real time to address feedback and turn around revisions. Spend less time managing the review process and more time on your high-priority to-dos. Pepper Flow is cloud-based, enterprise-grade software that enables life science companies to improve their competitive advantage, market products with efficiency, and maintain rigorous compliance. You need to move fast in order to deliver content to your key audiences. Pepper Flow’s intuitive interface allows you to get work done quickly and effectively. -
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MSLInsight
MSLInsight
MSLInsight is a cloud-based platform designed for Key Opinion Leader (KOL) interaction management, specifically tailored for nascent life sciences companies in the pharmaceutical, biotechnology, medical device, and diagnostics sectors. It integrates all KOL insights into a unified platform, enabling Medical Science Liaisons (MSLs) to improve productivity and manage interactions efficiently. The platform provides a real-time dashboard for monitoring KOL interaction data and ensures compliance with regulatory requirements. MSLInsight helps streamline workflows by allowing seamless data integration and mobile access, enabling MSLs to record, report, and analyze interactions from day one. It enhances product awareness and adoption by facilitating the flow of information between companies and the medical community, supporting regional, national, and global efforts. Built on the Salesforce platform, the software is easy to implement and use, providing an affordable solution for companies. -
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Affytrac
Affygility Solutions
Affytrac is our secure EHS software for the life science industry, currently in use at biotechnology, pharmaceutical and medical device companies throughout the world. As a web-based tool, there's no software to install, and with our streamlined setup process, there are no delays in having your EHS program automated, optimally tuned, and always at your fingertips. Simple and intuitive to use, yet powerful and full-featured, Affytrac includes all the functionality you expect in EHS software, without any unnecessary complexity to get in your way. Task Management lets you define your organization's set of compliance and safety tasks. Assign to personnel, add your target dates, and Affytrac automatically notifies staff and tracks progress. Document and track Corrective Actions identified through accidents, incidents, safety committees, regulatory inspections, and risk assessments. -
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Medidata
Dassault Systèmes
The Medidata Clinical Cloud is our cutting-edge platform that transforms the clinical trial experience for patients, sponsors, CROs, and research sites. As the only unified technology platform dedicated to clinical research, the Medidata clinical cloud addresses the holistic research process from start to finish. Our platform helps life science and medical device organizations cut development costs, mitigate risks, and deliver treatments and devices to market faster. No matter which products you choose for your clinical trial program, you will have access to the power of the Medidata Clinical Cloud. At Medidata, we’re leading the digital transformation of clinical research. Powered by artificial intelligence, machine learning and advanced analytics, our platform brings researchers, study managers, investigators, and patients together to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials. -
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Salesforce Life Sciences Cloud
Salesforce
Salesforce’s Life Sciences Cloud is a comprehensive platform designed to support pharmaceutical, biotech, and MedTech companies throughout the product lifecycle—from clinical trials to commercialization. It combines AI-powered tools and data-driven insights to improve patient engagement, optimize medical inquiry response times, streamline clinical trial management, and enhance sales and marketing efforts. With capabilities such as intelligent HCP engagement, personalized patient services, and predictive analytics, Life Sciences Cloud empowers organizations to deliver personalized experiences, improve outcomes, and navigate regulatory complexities more efficiently. It integrates seamlessly with other Salesforce products and third-party tools to provide a holistic view of the healthcare ecosystem. -
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Sorcero
Sorcero
Sorcero is an AI-powered platform designed to transform complex medical data into actionable insights for the life sciences industry. With its suite of products, including Medical Insights Management, Intelligent Publication Monitoring, Plain Language Summaries, and Intelligent Systematic Literature Review, Sorcero unifies and analyzes unstructured and structured data from a variety of sources. By using AI to analyze medical themes, notes, and research, Sorcero delivers high-quality, easy-to-understand answers to complex medical questions, helping teams in Medical Affairs, Pharmacovigilance, and Regulatory Affairs drive more informed decisions. The platform supports rapid literature monitoring, content generation, and evidence-based decision-making, ultimately boosting patient outcomes and enhancing operational efficiency. -
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Infor PLM Optiva
Infor
Infor PLM for Process (Optiva®) is specifically designed for food, beverage, chemicals, and life science manufacturers and provides a unified product view of data and processes across organizations. It helps manufacturers easily achieve regulatory and labeling compliance, whether it’s meeting reporting requirements, complying with labeling laws, or supplying ingredient details. Project management capabilities give the right people the right visibility into project data, from concept, to development, to final sign-off. Reckitt Benckiser (RB), a British multinational consumer goods company, adopts modern PLM capabilities using Infor® PLM for Process to boost global safety and compliance and get one version of the truth about its products, from development to manufacturing. Integration capabilities with ERP systems helps provide better insight into costs.
