Best Regulatory Information Management (RIM) Systems in China

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.

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.

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

The Vault RIM Suite offers a comprehensive platform for managing regulatory information from end to end. By centralizing global regulatory workflows on a cloud-based system, it enhances visibility, data quality, and responsiveness for life sciences organizations. This allows companies to adapt swiftly to shifting regulations while improving efficiency throughout the submission process, from planning to final publication. The platform facilitates collaboration among headquarters, affiliates, and partners, all within a unified RIM system. Furthermore, it guarantees that teams produce regulatory content that is both reliable and maintains high data integrity. Veeva Vault Registrations oversees product registration details on a global scale, covering registration status, variations, and interactions with health authorities. Its adaptable data model is designed to incorporate IDMP data points and will keep pace with changing regulatory data standards. Additionally, Veeva Vault Submissions optimizes the submission planning process by automating various steps in the regulatory workflow, leading to significant time savings and improved outcomes. This unified approach ultimately empowers companies to navigate the complexities of regulatory compliance with greater ease and precision.

Gain all the necessary resources to effectively register your medical device or IVD product in global markets while overseeing your market access license throughout the product's life cycle. REGISLATE® equips users with comprehensive submission file requirements tailored to specific medical and IVD device needs for each country. With this platform, you can monitor milestones, timelines, as well as estimated and actual completion dates for initial registrations, renewals, amendments, and license transfers as they happen. Additionally, it offers infographic data and exclusive indicators to facilitate transparent oversight and management of every project. Take advantage of collaboration tools that assist in the preparation and review of submissions, ensuring compliance with all necessary requirements and documentation. Stay informed with real-time progress reports on both current and upcoming submissions, including insights into market access readiness. Furthermore, REGISLATE® features GR-MAP registration tracking, providing comprehensive oversight for both the country and product involved. This holistic approach ensures that users are well-equipped to navigate the complexities of market access efficiently.

EXTEDOpulse offers a robust RIM software suite with five interconnected hubs that cover all phases of pharmaceutical product development. Users can either utilize the applications independently or enhance their experience by combining them according to specific needs. The process of developing pharmaceutical products is intricate, requiring collaboration and input from various departments within an organization. Additionally, navigating the challenges of a strictly regulated industry heightens the difficulties faced by life science organizations with each product launch. Our deep understanding of the life sciences landscape enables us to foster synergy, connectivity, and innovation, ensuring seamless compliance. Designed with these challenges in mind, EXTEDOpulse facilitates connections throughout the entire lifecycle of pharmaceutical products, streamlining operations and enhancing efficiency. Ultimately, EXTEDO recognizes the complexities involved in the regulated journey of pharmaceutical products and aims to simplify them for its users.

Introducing a comprehensive global regulatory affairs platform, featuring registration management tools and expert support from regulatory professionals worldwide. This system is essential for initiating, renewing, modifying, or transferring market access approvals for your medical devices or IVDs. With LICENSALE®'s user-friendly interface and real-time data capabilities, you gain access to complete project management tools, infographic analytics, a seamless collaboration space, future market access strategies, and detailed reporting features. This empowers you to oversee your global medtech registration processes effectively. Regulatory specialists from Arazy Group meticulously examine your compliance documents, providing guidance in the preparation and submission of your applications, and they liaise with authorities until you secure the necessary marketing approvals. Furthermore, LICENSALE® encompasses specific submission and compliance requirements tailored to your product across over 140 countries, with dedicated regulatory experts available to assist in navigating each market's unique challenges. By leveraging this system, you can streamline your regulatory processes and enhance your overall market entry strategy.

Regulatory responsibilities rely heavily on expensive contributors within various regulatory materials. A cloud-based solution such as the Infosys regulated document management platform effectively addresses these challenges. It allows for externalization and collaborative authoring and editing of documents, thus simplifying governance and processes while implementing a consumption-based commercial model that includes support for audit trails. Additionally, it facilitates the creation of custom workflows and offers assistance with versioning, all backed by a proven solution that guarantees 99.95% uptime in production environments. This innovative system enables business users to swiftly locate documents from an extensive repository in just three to four seconds. Furthermore, users benefit from unlimited on-demand storage, enhancing their ability to manage data efficiently. The DMS leverages Google application programming interfaces (APIs) to minimize operational and maintenance expenses, ensuring that the company's overhead costs are confined to API usage and storage requirements. By adopting this advanced platform, organizations can significantly improve their regulatory compliance processes while also cutting costs.

In light of the constantly evolving national regulations and the intricate nature of preparing for regulatory submissions, organizations within the healthcare and life sciences sectors are increasingly focused on adopting smarter methodologies and intelligent systems to enhance efficiency, reduce costs, and shorten submission timelines. To tackle these challenges, RIMTrack emerges as a cutting-edge regulatory information management system that leverages cloud-ready artificial intelligence. Built from the ground up, its primary goal is to assist organizations in achieving precise and effective submission preparations while streamlining the various regulatory processes involved in tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and comprehensive reporting across international stakeholders. By integrating seamlessly with existing Regulatory Information Management systems, RIMTrack facilitates a thorough end-to-end management of the entire regulatory lifecycle, ultimately empowering organizations to navigate the complexities of compliance with greater ease and accuracy. Such advancements not only improve operational efficiency but also position organizations to adapt more readily to future regulatory changes.

Enhance your regulatory operations with our comprehensive, all-in-one regulatory information management solution, IQVIA RIM Smart. By alleviating your team's burden from tedious maintenance tasks, they can concentrate on bringing valuable products to market. RIM Smart represents a cutting-edge approach to regulatory information management, designed to accelerate processes, foster collaboration, improve efficiency, and provide greater visibility across your global portfolio, all while optimizing performance and reducing costs. This secure cloud-based platform offers an integrated, holistic, and intelligent method for managing the entire regulatory workflow. The integration with IQVIA’s safety and quality platform will boost performance and offer increased adaptability. By automating manual tasks and enhancing connectivity, you can achieve not only improved efficiency but also significant cost savings, leading to better coordination and visibility across your enterprise. Embrace this transformative system to ensure your regulatory processes are both modern and effective.

OpenText™ Information Management solutions empower organizations in the life sciences sector to harness data and content insights, enhancing their decision-making and speeding up product development. These tools enable seamless integration, management, and secure sharing of information among individuals, systems, and devices. By utilizing information assets effectively from research and development through to commercialization, organizations can benefit from adaptable cloud-native software that operates in any environment. OpenText for life sciences significantly accelerates the discovery process, facilitating the extraction of actionable insights that foster innovation in the pipeline. Users can convert research papers into electronic lab notebooks through intelligent capture, and uncover valuable insights using text mining techniques. Moreover, the platform allows for the extraction of knowledge hidden within unstructured text of clinical trial reports, study protocols, and findings related to clinical safety and efficiency. It also offers methods to intelligently analyze, categorize, and extract information from clinical trial documents, ultimately minimizing the risk of expensive delays and interruptions in the development process. By effectively utilizing these advanced capabilities, life sciences organizations can significantly enhance their operational efficiency and drive forward their research initiatives.

RIMExpert™ effectively streamlines regulatory planning, tracking, and data management by overseeing global rollout strategies and automating the preparation of regulatory applications, activities, and medicinal products. By minimizing data entry requirements, RIMExpert™ enhances data integrity while boosting global oversight and control. The platform standardizes processes related to regulatory planning, tracking, and registration management, which in turn fosters improved collaboration between headquarters and their affiliates. It also establishes a centralized workspace for all registration-related activities. This single access point consolidates all inquiries, commitments, correspondence, and authorizations for each application, thereby synchronizing efforts to achieve optimal efficiency in enterprise regulatory resources. RIMExpert™ enables precise control over registration activities throughout a product's lifecycle, ensuring that timelines and the status of commitments and agency inquiries are continuously monitored. Additionally, it features interactive dashboards that provide a comprehensive overview of regulatory activities and registrations, empowering teams to make informed decisions and take timely actions. In this way, RIMExpert™ not only enhances regulatory compliance but also drives organizational effectiveness.

Samarind RMS offers an intelligent solution for overseeing your medical product information more effectively. With Samarind RMS, you can input data just once and utilize it repeatedly as needed. For instance, an ‘INN’ can be registered once and applied to all associated IMA submissions, renewals, variations, PSURs, and XEVMPD submissions. This principle is applicable to all essential data maintained within the system, which has demonstrated its ability to enhance workflow efficiency and boost data quality. Our practical approach to system design and implementation allows clients to handle their licenses with ease and confidence, knowing that our single-source-of-truth™ strategy for regulatory affairs experts provides a comprehensive end-to-end solution. Additionally, our platform includes an electronic document management system (EDMS) equipped with version control, the creation of templates, and the capability to connect to external document management systems such as Documentum™ or SharePoint™, ensuring a seamless integration of all your documentation needs. Ultimately, Samarind RMS empowers users not only to manage their information but also to improve collaboration across different departments.

Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.

PhlexRIM is set to significantly enhance compliance by providing real-time access to global registration data in a highly efficient manner. The latest version, PhlexRIM 2.0, features a collection of pre-configured automation assistants, known as “bots,” along with built-in regulatory scenarios that adhere to industry best practices. With an easy-to-use drag-and-drop design interface, regulatory teams can streamline their business operations without needing programming skills or assistance from IT departments. Furthermore, it allows for effective management of the pharmaceutical product registration lifecycle. Users can access detailed status updates and take advantage of the alert management system integrated into all workflows. Reporting capabilities are also robust, enabling the use of standard reports or the creation of custom reports tailored to specific needs. Additionally, the platform facilitates the creation and assignment of regulatory tasks within various levels of the organization, including management, departments, headquarters, and affiliates, ensuring cohesive collaboration across teams.

Envision having all your regulatory details related to products, registrations, submissions, correspondence, and commitments consolidated in a single, easily accessible location. With Ennov RIM, companies in the life sciences sector can enhance their regulatory workflows, elevate data integrity, swiftly address crucial business inquiries, and efficiently fulfill requests from health authorities. Specifically designed for the oversight and monitoring of therapeutic product information and registration data, Ennov RIM is rooted in Ennov Process. Regardless of whether you are preparing for the introduction of a new product or managing adjustments to current registrations, Ennov RIM equips regulatory teams with essential information and tools to proficiently oversee product portfolios on a global scale. This comprehensive approach not only fosters compliance but also promotes strategic decision-making across the organization.

Enhance the speed at which products reach the market by organizing, implementing, and monitoring all regulatory processes within a cohesive RIM application that offers easy access to regulatory documentation and comprehensive support for major eCTD submission standards. The integrated automation simplifies workflows, minimizing administrative tasks and increasing trust in the quality of product registration data. By utilizing this unified approach, organizations can ensure a more efficient regulatory process while maintaining high standards of compliance and accuracy.

Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.

Freya is an advanced AI regulatory assistant that simplifies the process of understanding and navigating complex regulations. By leveraging a vast database of over 40,000 global regulations, Freya provides real-time, verified answers to regulatory questions and offers tools like document translations and summaries. The platform supports compliance management by offering up-to-date regulatory information, ensuring businesses stay informed and efficient. Powered by AI and verified by industry experts, Freya enables organizations to make faster, more accurate decisions while managing their regulatory obligations across multiple markets.

At Calyx, we understand that the foundation of a successful clinical development initiative lies in the quality of your data, which underscores the importance of an efficient electronic data collection (EDC) system. Employed in over 2,600 clinical trials globally, Calyx EDC facilitates the streamlined collection and reporting of clinical trial data through a user-friendly platform. It’s essential to safeguard your critical data with a reliable partner—reach out to us to discover how Calyx can enhance the success of your program. With Calyx EDC, you gain the adaptability to effortlessly plan, design, and execute studies of any complexity. Its features are crafted to lower costs, enhance site visibility, and boost efficiency, ensuring your trial remains on course. Trust Calyx to be the ally you need for navigating the complexities of clinical trials.

ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.

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.

ClinChoice excels in overseeing international regulatory information by leveraging advanced technology, a comprehensive grasp of both global and local regulations, and exceptional data management techniques. By harnessing its regulatory affairs and technological expertise, ClinChoice aids organizations in effectively handling their regulatory data. Our team of consultants offers essential data maintenance assistance within regulatory information management system (RIMS) software, facilitating timely application submissions, approvals, and renewals while enhancing operational efficiency and monitoring. We support the management and oversight of the drug registration process, enabling pharmaceutical and medical device manufacturers to maintain visibility and track all regulatory details. With our guidance, organizations can formulate both immediate and long-term strategies that ensure compliance with submission deadlines, all while minimizing disruption to their everyday operations, ultimately contributing to a smoother regulatory journey. This strategic partnership empowers companies to navigate the complexities of compliance with greater confidence and agility.