Alternatives to Rimsys

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.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

Compliance & Risks works closely with some of the most prominent brands in the world, including Dyson, Caterpillar and Samsung. We simplify the Product Compliance process to unlock market access. Three key elements are part of our offering: 1. Enterprise technology solution to improve productivity and efficiency with C2P The market's most comprehensive regulatory content, with 40+ topics covering over 20+ industries and 195 nations worldwide. 2. A team of subject matter experts are available to answer any regulatory questions you may have 3. We help you to monitor and assess the relevant regulations and standards that apply to your products and business. We also help you prove product compliance in order for your business to remain on the market and grow. We have over 20 years experience working with some of the most iconic brands in the world and have a remarkable track record of helping companies to manage compliance risks more effectively than ever.

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.

With meddevo, each team member has a workspace where they can create, manage and automate technical documentation of medical devices and IVDs. A turnkey SaaS. Run Changes, CAPAs, complaints and custom processes directly in the system. Due to the full eQMS/eTD sync, you will gain maximum insight. Reduce the administrative burden and process time to a minimum.

Essenvia delivers business value to all departments and teams, and increases efficiency across the board. Centralized repository of all regulatory information allowing collaborative authoring, reporting, and eliminating technical holds, RTAs and RFIs. The regulatory affairs department is empowered to accelerate product launches, and eliminate revenue losses due to delays in submissions and missed renewals. Helicopter view over the entire regulatory lifecycle. Executive dashboards, metrics and proactive alerts are available for global registrations and submissions. Essenvia, a RIM Platform, allows you to manage regulatory workflows throughout the entire product lifecycle. It also accelerates global market access and generates exponential business value. Consolidate all regulatory activities onto one platform to bring your devices faster to market. All registration documents linked to product master information are stored in a central repository. Manage the product registration lifecycle per country.

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.

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.

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.

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.

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.

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.

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.

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.

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.

DXC RIM platform manages regulatory content, data and workflows in one central place. This helps teams accelerate innovation and reduces time to market. A unified platform is required to manage regulatory data and workflows due to the sensitive nature of regulatory affairs content (RA). All relevant data must be easily accessible to all teams. They also need an intuitive, customizable user interface that is simple to use. While configurable reporting and collaborative tools are essential for success, legacy technology can frustrate teams or slow down processes. Compliance is difficult. It is difficult to collect data and document processes. Life sciences organizations that use disparate technologies and have fragmented legacy systems can create problems. They may need to resort to spreadsheets in some cases to manage key operational processes. A centralized enterprise-grade solution is required to bring products to market and manage RA.

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™.

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.

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.

Dow Jones Risk & Compliance, a global provider, provides best-in class risk data, web based software applications, and scalable due-diligence services to help organizations manage risks and meet regulatory requirements in relation to financial crime, third party risk management, international trade, and sanctions. Dow Jones Risk & Compliance is built on the legacy of the world's trusted newsroom. It combines the expertise and knowledge of a multilingual team of researchers with the industry-leading data scientists, technologists and analysts to provide actionable compliance content. Our solutions were created in partnership with leading legal and political advisors, including former regulators, to help our clients maintain consistency among global business units and teams.

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.

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.

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.

AmpleLogic Regulatory Tracker is built using the LOW CODE AND NEUTRAL CODE (LCNC PLATFORM) and consists of two modules: ANDA Tracker and DMF Tracker. This Pharmaceutical RIMS Software will help you improve data quality, increase operational efficiency, reduce mistakes, and streamline communications across departments.

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.

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.

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.

Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.

No matter what industry you are in, businesses, governments, and communities all over the globe are dealing with a changing regulatory landscape. This means regulatory change, increased government and public scrutiny of companies' activities and compliance with regulatory requirements. Totum is a cloud-based software company that specializes in compliance management software. Totum Compliance was originally developed for the highly-regulated oil & gas industry. It provides an automated and holistic approach to managing local and global compliance requirements. It also delivers timely and relevant information to operational team members. Our single source of truth allows companies to manage the complex and varied obligations they have to meet in order to maintain their legal and social licenses to operate anywhere in the world.

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.

The state of global affairs has made the sanctions landscape more complex and dynamic than ever before. It is more important than ever to ensure that proper due diligence is done and that risk management processes are in place. All aspects of a trade transaction can be subject to regulatory risk: the goods being traded and their origin, buyers and sellers, cities and ports along the shipping route and the ships themselves. PurpleTRAC is designed for and by companies that have regulatory exposures in maritime shipping and maritime trade. It automates, streamlines, and records your regulatory processes. It also reduces the risk of money laundering or terrorist financing.

Solidus Labs is the first digital asset-specific automated, comprehensive, and testable market surveillance and risk monitoring platform. Legacy solutions are unable to keep up with digital assets' complexity and pace. Solidus Labs' award winning solutions are easy to adapt, reduce costs, and meet all regulatory requirements. All compliance can be managed in one place, minimizing risk and costs. Our solutions combine multiple risk signals into one consolidated platform. You can save the time and expense of adapting legacy solutions. Solidus was built from the ground up to meet the challenges of digital assets. Constructed in conjunction with evolving industry standards and regulatory insight. Our software and regulatory network allow for licensing in all jurisdictions. Our solutions combine decades of compliance best practices with state-of the-art machine learning.

Select the only solutions that you need right away. You can add more capabilities later on. The LORENZ Foundation manages Controlled Vocabularies and Repository Management, Interoperability Management, and User Management. This centrally streamlines system management, maintenance, and deployment. You can benefit from a network that integrates with other specialized systems. LORENZ solutions are compatible with third-party software. This gives you the freedom to choose the perfect fit for you, even if it is not in the LORENZ portfolio.

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.

vFinance, a Belgian fintech company, specializes in back office management software and outsourced services for loans and other insurance products. The vFinance platform allows for automated product management throughout the entire contract life-cycle. This includes accounting, regulatory, reporting, and commercial requirements. More than 20 successful projects have given rise to deep migration experience. Everyday efficiency is achieved by converting business processes directly into accounting entries. Reversible transactions are a sign of operational excellence, taking into consideration all legal, regulatory and accounting principles. High regulatory compliance standards, including full audit trail, logging, and incorporation de 4-eyes principles. Platform robustness is achieved through operational and development excellence. Product evolution and innovation can be made possible by flexibility and parametrization.

Our flexible, scalable and easy-to-use solutions offer a 360-degree view on employee and business activity. This allows firms to monitor and reduce risk, meet regulatory requirements, gain efficiencies, and encourage employee adoption.

This portal was created to help you keep abreast of the latest regulatory developments and to increase your knowledge and understanding about Global Fund Regulations. As regulatory compliance becomes more complex and more difficult, we are at the point where regulation and opportunities become intertwined. Funds-Axis is here. One, integrated solution that can be used to manage all aspects of your investment compliance, risk management, and regulatory reporting. We provide a unified approach. Global solution. One central hub for all your reporting obligations. Supported and guided by one talented team. We are multi-jurisdictional, multi-faceted. We are familiar with regulatory complexity and the changing requirements.

Transform the way you meet your regulatory and compliance reporting obligations. We are a team made up of regulatory experts, data engineers, and technology developers who are focused on improving the quality of data and finding new solutions for complex regulatory challenges. Our award-winning solutions help clients in the financial services sector, from boutique asset managers to tier-one banking, meet regulators' demands. Get accurate, complete and timely regulatory reports. Search, share and manage regulations on a single digital platform. Automated reporting and monitoring of shareholding disclosure. A holistic approach to managing market abuse and misconduct. Automated research management reduces regulatory risk. Accredited training on a variety of regulatory reporting regimes. We are regulatory and information specialists on a quest to revolutionize how people work with compliance.

CUBE RegPlatform, our world-leading SaaS platform, is trusted and highly regarded. It provides the most complete source of meaningful, classified regulatory intelligence for large financial institutions worldwide. Our RegPlatform product combines industry-leading technology with expert validated insights to provide a future-proof, continuously up-to-date service that simplifies multi-jurisdictional regulatory compliance. RegPlatform is made up of a variety of modules that can be customized to meet your compliance and business needs. RegPlatform is the trusted partner of large financial institutions looking to improve regulatory compliance on a global level. Our philosophy is based on the Three R's. We deliver timely, relevant regulatory information that reduces compliance risk. We do this by leveraging the most advanced techniques in artificial intelligence, such as machine learning and natural language processing.

Moody's Analytics' regulatory reporting solution provides comprehensive, automated and streamlined regulatory reporting for Basel I and II and III and IFRS 9. ECB, CCAR and DFAST stress tests. It supports regulatory reporting to more than 50 regulators worldwide. This award-winning solution uses Moody's Analytics data management platform, regulatory capital calculation engines, to provide accurate, streamlined and automated regulatory reporting. It consolidates the regulatory capital calculations banks require to populate a wide variety of regulatory reports. This helps banks align their regulatory reports and ensures they present a consistent picture across multiple reporting systems. Its report templates can handle complex banking regulatory reports. They also support a variety of formats, including Microsoft Excel, XBRL and ASCII. Reporting managers can view the results across the entire company by using powerful OLAP data cubes.

Nimonik provides access to standards developed by 40+ standards development organizations, including ISO, IEC and API, as well as IEEE, ASTM, ACI, ACI, IEEE and many more. Nimonik offers access to laws, regulations and other information from more than 500 states and countries around the world. This data is integrated in Nimonik's tools for workflow management and allows companies to manage their compliance and issue reports. Global Standards and Regulatory Compliance Software. Software that helps organizations identify and extract requirements from regulatory documents, standards, contracts and permits. Compliance Management System (CMS) and Audit Software A central platform for managing compliance obligations and conducting audits. Newsletter & Library Regulatory Updates. A service that provides updates on regulatory trends and changes, helping businesses to stay informed and compliant.

Unprecedented levels of regulatory complexity and change are continuing to affect the banking, financial services, and insurance sectors. Thomson Reuters Regulatory Intelligence provides a single solution that empowers compliance professionals and gives them the tools to make proactive and effective decisions within their organizations.

DFIN, the leading global provider of risk and compliance solutions, is the only company that offers regulatory, reporting and legal solutions, as well as filing and distribution solutions, through a single integrated financial compliance management platform. We offer the financial industry the experience and expertise that comes with being a market leader. Arc Suite's financial regulatory compliance software allows you to meet the challenges of a constantly changing regulatory environment. The platform supports a full spectrum of data and multilingual content. It also meets compliance needs. Arc Suite was developed by experts in mutual funds and product technology, to meet the reporting requirements of the SEC, OSC and ESMA. Arc Suite's regulatory management software supports front, middle and rear office operations using cloud-based proprietary tools.

No matter how experienced or novice you are with the regulatory submission process, you should not take the risk of your electronic common technical documents (eCTDs) being rejected lightly. This is especially true given the evolving regulatory environment. There are also differences in eCTD submission requirements by region. This makes it difficult to manage the entire document lifecycle and meet your organization's goals for accelerating your release to market. Certara's GlobalSubmit™, eCTD submissions management program, will give your regulatory team the tools to publish, validate, review, and approve your eCTD submitted documents. You can reduce risk and avoid unnecessary steps by using a simplified eCTD submissions process that supports your regulatory department as they race to meet deadlines to deliver treatment to patients. It is crucial that your eCTD submissions are filed as your regulatory department races for treatment delivery and deadlines.

SmartInsights™, Global Market Access Platform, is an online subscription service that allows you to quickly and easily find current, accurate, and complete regulatory requirements for global markets access. The interface is user-friendly and designed to help you achieve global compliance. Access to key regulatory data and information that is essential for the day-to-day management and strategic business decisions. This includes entering new markets and introducing new products. Access to the most current information about the regulatory landscape and new or updated regulations in your product category. The database is constantly updated to ensure you have the most current information. Access can be customized according to the country and product categories that you require.

Product Comply provides 360-degree monitoring of the evolving regulations and standards that impact your products. Our software can be customized to suit any compliance landscape, whether it's electronic products, medical devices, furniture, cosmetics, or any other product. Our product compliance software is able to navigate all global regulations related to any subject related to safety, health, and the environment. The regulations are then mapped to your product portfolio based on components, materials, or chemicals to ensure you stay ahead of any regulatory changes that could impact your business. Advanced software that monitors regulatory changes is essential to ensure your business is protected.

Technology has revolutionized the process of identifying and understanding global financial regulatory rules. This technology will make Financial Regulation Easy. Financial Regulation is made easier by AI-driven regulatory compliance and change management. Finreg-E uses machine learning and artificial intelligence to automatically extract key regulatory actions, connect them with internal controls, and provide intuitive workflows to ensure compliance. Finreg-E's unique regulatory compliance and change management software uses innovative technology to automate and improve compliance with global financial regulatory rules. Finreg-E dynamically links regulatory requirements to internal policies and procedures, using technologies such as artificial intelligence and natural language processing.

Only SAS offers a cloud-native, open statistical computing environment with embedded analytic software, support for data standardization, and optionally integrated analytic apps. Our analytic platform for clinical research can help you modernize and bring new therapies to market quicker to improve health. Manage and analyze data in a collaborative environment, streamline processes and deliver results more efficiently to regulatory authorities. Cloud-native solution for clinical analysis, submission, and audit trails. Includes everything you need to validate, comply with regulatory requirements, manage versioning, audit trail, and support documentation. Automated workflows, support of current and future integrations and proper management of data standards and controlled terminologies. Includes a central hub for all data, automated data analysis, better management, and analytic data preparation.