Best Regulatory Information Management (RIM) Systems in Japan

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. 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! 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. 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.

Secure Multi-Data Archiving with a Single Interface OneVault archives email and all new data types that your organization uses today. Email, Instant Messaging and Teams, Zoom, Webex, and many other data types. OneVault gives you a single interface to archive from multiple systems. It is easy to organize consistent policies and support business continuity plans by centralizing important data in a secure cloud platform. e-Discovery is a single platform for managing and working with records. It is secure, transparent, and easy to use. OneVault combines the powerful features of our stand alone archiving solutions under one pane of glass. It is intuitive, secure, and scalable. Start with email and expand as new systems become available.

The RecordPoint Data Trust platform helps highly regulated organizations manage data throughout its lifecycle, regardless of system. We work with organizations in highly regulated industries to ensure their data is right where it should be - safeguarded for privacy, security, and governance.

harmon.ie allows knowledge workers to easily capture and classify email and documents to SharePoint and Teams from Outlook, where they spend most of their work time. It is easy to find and share important content right from your email client. harmon.ie makes it easy to do the right things, increasing SharePoint adoption and workplace productivity as well as information governance compliance. Thousands of enterprise customers rely on harmon.ie's SharePoint- and Office 365-based user experiences products for email, records management, collaboration, knowledge preservation, and SharePoint adoption. harmon.ie is a Microsoft Partner since 2003 and has won many Microsoft Best App Awards. Our flagship solution eliminates data silos in Office 365 apps by grouping information with Descriptive Labels. harmon.ie SmartAssistant allows organizations to bring together all their information so that employees can concentrate on work.

Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners. Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.

EXTEDOpulse, a comprehensive RIM software solution, consists of five hubs that address all stages of product development. You can use the applications separately or combine them to get additional value based on your needs. The development of pharmaceutical products can be complex and require input from many people. Life science organizations face many challenges due to the complexity of operating in a highly regulated industry. We are able to provide you with great synergy and connection, as well as innovation, for compliance. EXTEDOpulse was designed with these aspects in view to help you connect the dots throughout the entire lifecycle pharmaceutical products. EXTEDO is familiar with the complexities involved in the regulatory pharmaceutical product journey.

Calyx understands that data is key to the success of any clinical development program. Your electronic data collection (EDC), system is crucial to your success. Calyx EDC is used in more than 2,600 clinical trials around the world. It streamlines data collection and reporting through one platform. Don't give your sensitive data to anyone. We can help you make your program a success with Calyx. Calyx EDC allows you to plan, design, and carry out studies of any complexity. Calyx EDC helps you keep your trial on track with features that reduce costs, improve site visibility and drive efficiency.

ViSU™, a cloud-based End-to End Regulatory Information Management platform (RIM), is specifically designed for the medical device industry. It allows global users to access and manage regulatory data (Product Master and Registrations, Tracking), Dossiers/Tech files (Submission planning and building & lifecycle), HA/NB correspondence and Obligations tracking. ViSU helps you embrace digitalization in regulatory. It provides connectivity, traceability, and automation which leads to regulatory management efficiency, lower compliance risks, and cost reduction.

RegDocs Connect provides the tools for your regulatory and operational teams to create compliant, submission-ready documents and records. This solution is built with the end user in view. It focuses on collaboration, automation, and quality. Automated workflows allow you to manage your records from draft to final. This allows your team to have complete control over your regulatory documents at any time. The mapping of document types to the EDM Reference Model and eCTD allows for organization and retrieval of documents that can be used in regulatory submissions. The powerful tools of PDF/A Publishing, document classification, unique document identifiers, and EDM reference model facilitate regulatory document management. This solution pulls together information from all levels of your organization into one easy-to-use solution. The ability to produce submission-ready and quality content has become more difficult due to electronic submissions to regulatory authorities and the complexity of drug development.

End-to-end regulatory information management from a single platform. The Vault RIM Suite streamlines global regulatory process on a single cloud-based platform. This allows life sciences companies to increase visibility, data quality, agility, and efficiency. You can respond faster to changes in regulations and improve process efficiency, from submission planning to publication. Coordinate regulatory efforts across HQ and affiliates within a single RIM platform. Assure that teams are creating reliable regulatory content with high data integrity. Veeva Vault Registrations manages product data worldwide, including variations, registration status, and interactions with health authorities. Veeva's flexible data structure supports IDMP data points, and will continue to support changing regulatory data standards. Veeva Vault Submissions automates regulatory process steps and streamlines submission planning.

Our enterprise document management software is the best in its class. Meridian offers a single source for truth and configurable workflows that streamline collaboration with all departments. It also ensures that every document change is versioned, audited, and reported to the regulatory authorities. Engineering document management refers to the process of finding, finding, and managing complex engineering documents, including CAD files, drawings, technical documents, and communication documents, in AEC organizations (Architecture, Engineering & Construction). Businesses in these industries can find it difficult to manage their engineering documents effectively. Meridian's document management software for engineering projects can address these concerns. Meridian can centralize documents and drawings within an organization while automating key processes.

All the information you need to register your IVD product or medical device in any market worldwide and manage your market access licence throughout the product's life cycle. REGISLATE®, which provides information about medical and IVD device-specific submission file requirements for each country, allows users to manage their market access licenses through the product life cycle. You can track milestones, timelines, estimated and actual completion dates, as well as estimated and actual completion dates, for initial registrations, renewals, amends, and license transfers, in real-time. For clear monitoring and management, infographic data and proprietary indicators are available. Collaboration tools are available to assist with the preparation and review submissions, compliance requirements, and documents. Receive progress reports in real time for current and future submissions, including market access readiness index. REGISLATE®, which includes GR-MAP registration tracking, for both country AND product.

Global regulatory affairs system that includes registration management software and support from regulatory experts around the world. This registration system is required to renew, amend, transfer, or modify your IVD market access approval or medical device. The intuitive user interface of LICENSALE®, which includes real-time data and infographic analytics, allows for project management, collaboration, future market access planning, advanced reporting, and effective project management. It allows you to take control of your global medical technology registration activities. Arazy Group's "in-country regulatory experts" review your compliance documents and assist in the preparation of your applications. They will work with authorities until you receive your desired marketing approvals. LICENSALE®, which includes compliance and submission requirements for your product in over 140 countries, as well as regulatory experts to help you with each market.

High-cost contributors are essential for regulatory functions. They can be found in a wide range of regulatory content. This problem can be solved by a cloud-based solution like Infosys' regulated document management platform. Externalization, collaborative authoring, and editing. Simplify governance and processes; implement a consumption-based model. Support audit trails. Implement a proven solution that guarantees 99.95% uptime in production. Our solution allowed business users to search documents in a vast repository in just 3/4 seconds. Users also had unlimited storage on-demand. To reduce operational and maintenance costs, the DMS uses Google's application programming interfaces (APIs). The company's overheads are restricted to API usage and storage space.

The regulatory affairs departments in the healthcare and life science industry are driven to improve efficiency and create intelligent systems that optimize costs, maximize accuracy, and reduce submission times. RIMTrack, a cloud-ready, artificial intelligence (AI)-based, new age regulatory information management system, addresses this concern. It was created from scratch to assist organizations in preparing submissions accurately and efficiently. It streamlines regulatory processes related to licensing, approvals, regulatory, competitive intelligence, clinical trials and reporting across global stakeholders. Integrate with existing RIM systems to achieve complete management of the regulatory lifecycle process.

IQVIA Smart, our new end-to-end regulatory information management software, streamlines regulatory processes. Your team can focus on delivering high-quality products to the market instead of labor-intensive maintenance. RIM Smart, the modern regulatory information management system, is designed to improve speed, collaboration, efficiency, visibility, and performance across your entire global portfolio. It also reduces costs. IQVIA RIM Smart is a secure cloud-based solution that allows for interconnected, comprehensive, and intelligent management of all regulatory processes. IQVIA safety platform integration will increase performance and improve flexibility. Automate manual processes and increase connectivity to improve efficiency, cost savings and coordination as well as cross-enterprise visibility and visibility.

OpenText™, a leading provider of information management solutions for life sciences organizations, helps them to harness insights from data and content to improve their decision-making and accelerate product development. Integrate, manage and securely exchange data between people, systems, and things. Use information assets to drive innovation and commercialization. Cloud-native software can run anywhere, giving you freedom of choice. OpenText for life sciences accelerates discovery by delivering actionable insights that can be used to drive innovation in pipelines. Intelligent capture allows you to capture and manage research papers in electronic lab notebooks. Text mining can help you gain insights. Unstructured text in clinical trial reports, study protocol, clinical safety and efficiency findings, can be used to extract knowledge. Learn how to intelligently analyze and classify clinical trial documents and extract them to reduce the risk for costly stops and starts.

RIMExpert™, which addresses regulatory planning, tracking, and data management, manages the global rollout plans and automates the creation of regulatory activities, medicinal products, and regulatory applications. RIMExpert™, reduces data entry requirements, improves data quality, and increases global oversight and control. Standardize regulatory planning, tracking, and registration management processes. Increase collaboration between affiliates and headquarter. All registration activities can be done in one place. One point of contact for all applications, questions, correspondence, and commitments. To maximize the efficiency of enterprise regulatory resources, sync your efforts. You can monitor registration activities throughout the product's lifecycle, keeping track of deadlines, status of commitments, and agency questions. Interactive dashboards to monitor and control regulatory activities and registrations.

Samarind RMS is a smarter way for you to manage your medical product information. Samarind RMS allows you to only enter data once, and you can reuse it as often as necessary. An example of this is the 'INN' which can be used once and reused for all IMA submissions, renewals and variations. This concept is applicable to all key data within the system. It has been proven to improve data quality and streamline workflows. 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), which includes version control, template creation, and the ability to link with external document management systems like Documentum™, SharePoint™.

ClinChoice manages global regulatory data with technology expertise, a deep understanding and best data management practices. ClinChoice uses its expertise in technology and regulatory affairs to help organizations manage their regulatory information. Our consultants offer general data maintenance support in regulatory Information Management System (RIMS) software. This will help ensure that applications are submitted, approved, renewed, and tracked on time. We offer the necessary support in managing and controlling the drug registration process. This allows drug and medical device manufacturers to track all regulatory information and has the ability to see it. Organizations can develop short-term and long-term strategies that meet submission deadlines with minimal impact on their day-to-day operations.

Kalypso offers life sciences companies a cost-effective accelerator to implement a RIM system - Accel for RIM. The integrated platform allows for efficient product distribution and management, as well as a global platform to track and manage product registrations. It consolidates compliance data and quality data from different enterprise solutions into one global source of truth to facilitate product registrations and tracking in order to speed up regulatory submissions. Modern APIs are used to combine product data, regulatory documentation, and submission packages. Pre-configured for quick implementation with a valid software system. Based on industry-leading RIM practices.

PhlexRIM dramatically improves compliance by providing you with real-time, efficient and effective access to your global registration information. PhlexRIM 2.0 includes a library of pre-configured automation "bots" and built-in regulatory use case examples based on industry best practice. The intuitive drag-and drop design tool allows regulatory teams to automate their business processes without the need for programming knowledge or IT support. Manage the entire lifecycle of pharmaceutical product registration activities. Access detailed status information and make use of the alert management feature that is part of all workflows. You can either use standard reports to illustrate your reports or create your own reports. You can create and assign regulatory tasks to your organization for management, headquarters, and affiliates.

Imagine all your regulatory information about products, registrations and submissions, correspondence, and commitments in one central place, accessible from anywhere. Ennov RIM allows life sciences companies to streamline their regulatory processes, improve data quality, quickly respond to business-critical questions, and effectively responds to health authority requests. Ennov RIM, a purpose-built application based on Ennov Process, allows for the tracking and management of therapeutic product details as well as registration information. Ennov RIM gives regulatory personnel the essential information and functionality they need to manage product portfolios globally, whether you're planning to launch a new product or handle variations to existing registrations.

You can speed up the time to market by organizing, executing and tracking all regulatory activities within a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality. You can speed up the time to market by organizing, executing, tracking, and planning all regulatory activities in a single RIM application. This allows you seamless access to all regulatory documents and full support for all eCTD submission requirements. Automation is integrated to streamline workflows and increase confidence in product registration data quality.