Best Regulatory Information Management (RIM) Systems in Europe

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.

ACE is a quality management software solution for companies of any size, in any stage, in any highly regulated industry. ACE is fully configurable allowing your company to adapt ACE to fit into your exact quality needs. Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.

Secure Multi-Data Archiving from a Single Interface OneVault archives email AND all the new data types your organization uses today. Email, Instant Messaging, Teams, Zoom, Webex & more. With OneVault you get a single interface to archive from many systems. Important data is centralized in a secure cloud platform that makes it easy to orchestrate consistent policies that also supports your business continuity plans. The single pane of glass for managing and working with records makes e-Discovery process secure, accountable, and best of all, intuitive to use. OneVault incorporates the powerful features of our stand-alone archiving solutions under a single pane of glass in an intuitive, secure, and scalable system. Start with email, expand as new systems are adopted where retention will either be required for compliance or just for ensuring access to de-facto operational commitments.

The RecordPoint Data Trust platform helps highly regulated organizations manage records and data throughout their lifecycle, regardless of system. The customizable platform is comprised of records management and data lineage tools that work together to give you full context of your data. RecordPoint’s capabilities span six core areas, which are the essential building blocks for solid data governance - data inventory, categorization, records management, privacy, minimization, and migration.

harmon.ie makes it easy for knowledge workers to capture and classify emails and documents to SharePoint and Teams directly from Outlook, the place they already spend their work time. As such, it is easy to discover and share important content when needed, right from the email client. By making it easy to do the right thing, harmon.ie increases SharePoint adoption, workplace productivity, as well as information governance and compliance. That is why thousands of enterprise customers count on harmon.ie's SharePoint and Office 365-based user experience products for email and records management, collaboration, knowledge retention, and SharePoint adoption. harmon.ie has won numerous Microsoft Best App awards and is a long time Microsoft Partner. Our flagship solution breaks down data silos from Office 365 apps, by grouping information using Descriptive Labels. harmon.ie SmartAssistant helps organizations bring together all their information so employees can focus on work

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.

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.

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.

At Calyx, we know that the success of your clinical development program comes down to data. Which makes the effectiveness of your electronic data collection (EDC) system key. Used in over 2,600 worldwide clinical trials, Calyx EDC streamlines clinical trial data collection and reporting—in one easy-to-use platform. Don’t trust your important data to just anyone. Contact us to learn how Calyx can propel your program’s success. Calyx EDC gives you the flexibility to easily plan, design, and conduct studies, regardless of their complexity. With features that help reduce costs, improve site visibility, and drive efficiency, Calyx EDC keeps your trial on track.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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™.

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.

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.

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.

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.

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.

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.

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.

Choose just the solutions you need right now. Later on, you will be able to add more capabilities with no problem. The LORENZ Foundation handles Controlled Vocabularies, Repository Management, Interoperability Management and User Management by centrally streamlining system management as well as maintenance and deployment. Benefit from a network of specialized systems that harmonize with each other. LORENZ solutions work flawlessly with third-party software, giving you the flexibility to choose your perfect fit even outside of the LORENZ portfolio.