Alternatives to Veeva Vault RIM

Predict360, by 360factors, is a risk and compliance management and intelligence platform that automates workflows and enhances reporting for banks, credit unions, financial services organizations, and insurance companies. The SaaS platform integrates regulations and obligations, compliance management, risks, controls, KRIs, audits and assessments, policies and procedures, and training in a single cloud-based SaaS platform and delivers robust analytics and insights that empower customers to predict risks and streamline compliance. Happy with your current GRC but lacking a true analytics and BI tool for intuitive executive and Board reports? Ask about Lumify360 from 360factors - a predictive analytics platform that can work alongside any GRC. Keep your process management workflows intact while providing stakeholders with the timely reports and dashboards they need.

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.

Global life sciences industry trusts us to drive intelligent engagement. Intelligent HCP engagement across all channels in real-time can improve customer experience. Data science and embedded intelligence can be used to provide customers with the most relevant and effective messages. Field teams should have access to the most current information and insights in order to plan and execute calls. Compliant note capture can help you build deeper customer relationships. Pre-built and custom visualizations provide tailored insights at the point where execution takes place. Veeva CRM allows commercial organizations to use artificial intelligence in the way they choose. Veeva CRM Suggestions is an open model that allows you to implement the best actions with any data science provider.

Risk management is best done in a fluid and powerful way. Your decisions today can help you mitigate the risks that you might face tomorrow. SAI360 is a cloud-first software that combines modern ethics and compliance content to help organizations navigate risk in a flexible and agile way. All the best in intelligent solutions and global expertise in one platform. Configurability of solution, extensible data model with configurable interface/forms, fields and relationships to extend solutions. Process modeling: Modify or create new processes to automate, streamline, and reduce risk, compliance, audit, and other activities. Data visualization and analysis. Many pre-configured dashboards that are easy to set up allow you to visualize and analyze data. Learning and best practices content - Preloaded frameworks, control library and regulatory content, along with values-based ethics, compliance learning content. Integration framework with APIs, and other protocols.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The enterprise content gap can be bridged to achieve global harmonization and local autonomy. Veeva Vault, a cloud-based enterprise content management platform that includes a suite of applications designed for life sciences, is a true cloud enterprise solution. Companies have traditionally had to deploy separate applications to manage data and content applications. Veeva Vault is a content management platform that can manage both data and content. Companies can now eliminate site, country, and system silos and streamline all aspects of commercial, medical, clinical and regulatory quality and safety. All Vault applications are built from the same core platform. This allows companies to gain efficiency and compliance by allowing for a seamless flow of documents between regions and departments. The content is always available, current, and in context throughout the entire development and commercial lifecycle.

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™.

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.

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.

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.

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.

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.

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.

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.

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.

RegulatoryOne replaces bespoke manual systems with a single authoritative regulatory management software solution that addresses all your compliance and regulatory requirements. This allows you to be more responsive to changing regulations. These efficiency gains increase your time to market while providing transparency across the entire organization with every product release gate a product passes through on its journey to market. RegulatoryOne, a cloud-based regulatory management software, unifies and coordinates all aspects of the regulatory process. This gives you visibility into what you are selling, when it can be sold, and where it is being sold - all from one place.

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.

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.

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.

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.

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.

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.

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.

Glemser offers IT solutions for regulated sectors with a focus in global life sciences and the ecosystem that enhances patient outcomes. ComplianceAuthor makes it easy for life science companies worldwide to manage product labeling, provide affordable IDMP, and reduce compliance risk. ComplianceAuthor for Global Labeling assists life science regulatory professionals to manage, scale, simplify, and streamline global product labels and compliance through artificial intelligence and structured content and natural language generation. Artificial intelligence and machine-learning are used to determine, index and derive the knowledge required to recommend the best course of action.

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.

Corlytics is a leading regulatory risk intelligence firm that partners with global regulators, financial institutions, and their advisors to provide data-driven insights for effective risk management. Founded in 2013 by CEO John Byrne, a serial entrepreneur in financial technology, the company is headquartered in Dublin, Ireland, with offices in London, New York City, Boston, and Sydney. Corlytics offers a comprehensive suite of services, including regulatory monitoring, taxonomy mapping, and regulatory advisory, enabling clients to navigate complex compliance landscapes efficiently. The firm's multidisciplinary team combines legal and regulatory expertise with advanced data analytics to deliver actionable intelligence. In recent years, Corlytics has expanded its global footprint through strategic acquisitions, such as ING SparQ, Clausematch, and Deloitte's RegHub, and has launched innovative platforms like Compliance Corylated, further solidifying its position as a trusted leader in the RegTech industry.

You might be more agile, more adept in identifying opportunities, and more able to anticipate changes. These are all powerful drivers of growth and competitive advantage. Risk Command is a collection of PwC Products that help you identify and monitor potential threats and help you respond and resolve them quickly and confidently. Identify high-risk movements and third parties before they have an impact on your business. You can save your business from financial and reputational damage by complying with regulatory requirements. Integrity Due Diligence allows you to request due diligence reports and perform focused risk-based monitoring. You can combine your operations and data into one view. This will allow you to capitalize on areas of convergence in compliance and fraud programs, and align operational data with corporate strategies.

Compliance Star is an online compliance software that provides the right tools to manage risk and monitor performance. Compliance Star allows remote management of FCA Authorised Firms, its operating Units/Agents and their operations via real-time data collection. It also provides reporting and reporting. Compliance Star, a technology-enabled compliance platform, facilitates compliance management, workflows and monitoring of firms authorized by the Financial Conduct Authority. Compliance Star is built on a calendar-based task management system that is 'fail safe'. This system allows for manual and automatic task setting, notifies actions, populates deadlines in a calendar, issues reminders, and monitors for completion. Leading regulatory networks are currently using the platform to reduce compliance burden. It allows for complete tracking of internal regulatory processes. It allows for single-point data access and the ability to generate FCA-required reports.

Infobelt assists companies to keep up with the complexity and volume of an ever-changing regulatory landscape. Infobelt helps reduce the risk of non-compliance through the implementation of policies and systems that improve the management and governance of regulated documents. Infobelt reduces data management costs through streamlining processes and the implementation of modern technologies. Infobelt provides decision makers with the tools, advice, and information they need to improve their firm's performance and increase their market competitiveness. Infobelt products can be integrated directly into a user's existing platform, which allows for easier maintenance and no hidden upgrades. Infobelt's platform encourages team collaboration through task workflows, user attestations, and team proactivity. A comprehensive compliance library is available to users that aggregates detailed regulations from many regulators.

In-app IMAP email, collaboration tools, and customer communication tools improve your communication with suppliers, customers, and team members. This simplifies coordination with all compliance stakeholders. Rumzerbot handles regulatory updates so that you can concentrate on your business. All plans include updates to regulations and declarable substances. Rumzer allows you to improve your supply chain communication and compliance process. Rumzer is not a middleman - we are your compliance software solution. All your compliance emails can be managed from one place. It's as simple as setting up an email account on your mobile device. Simply enter your email credentials, and you're done. You can add or remove users as many times as you like. To help you with compliance, you can add third-party service providers to your company.

Your accountability solution to GDPR compliance. You can enjoy a smoother and easier regulatory compliance process that empowers privacy professionals around the world. You can empower your privacy program using one smart, simple-to-use and secure tool. It also integrates automation to assist you in all your compliance tasks. Your compliance should be visible to your key stakeholders. Pre-designed, automated reports make it easy to communicate your results to the privacy team as well as to upper management. You have full control over your privacy administration. Smart automation can be used to standardize and streamline your processes. Ensure compliance with the GDPR and simplify your data protection efforts.

Vault Training helps ensure job readiness and compliance through the creation and management of role-based training requirements. Vault Training unites document management and training. It allows life sciences companies to manage authoring approval, assignment, assignment and assessment of critical training materials from one place. You can easily manage your training content and deliver time-sensitive assignments using a single suite of quality applications. You can easily assign tasks based on your job function or role. You can track and complete training tasks, or monitor status via a role-based homepage. Training tasks can be triggered by quality events such as approval of content changes, CAPA plans or periodic reviews. Automate training assignments based upon job functions and roles. You can track, monitor, and demonstrate the competencies of your employees. You can also see the status of your training assignments with delivered dashboards or reports.

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.

Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak's unified eClinical solution and related services improve efficiency and cost effectiveness for the clinical trial industry. Datatrak developed its multi-component, comprehensive solution using a single platform. This concept was expanded to include services delivery through Datatrak's Clinical and Consulting Services groups. The Company offers a complete range of software products that can be used to speed up the reporting of clinical research data to sponsors and regulators. This is faster than using loosely integrated technologies. Our goal is to empower workgroups with role-based access, version-controlled file management and calendar events, tasks, and contacts. All built within our eClinical software applications, including EDC, CTMS and reporting.

OmicsBox, a leading bioinformatics tool, offers end-toend data analysis for genomes, transcriptomes and metagenomes. It also provides genetic variation studies. The application, which is used by leading private and public research institutes worldwide, allows researchers to process large and complicated data sets and streamline their analytical process. It is designed to be efficient, user-friendly and equipped with powerful tools to extract biological insight from omics data. The software is divided into modules, each of which has a set of tools and features designed to perform specific types of analyses, such as de novo genome assemblies, genetic variations analysis, differential expression analyses, taxonomic classifications, and taxonomic classes of microbiome, including the interpretation of results and rich visualizations. The functional analysis module uses the popular Blast2GO annotating methodology, making OmicsBox a great tool for non-model organisms research.

SoftExpert ERM software allows organizations to analyze, evaluate, monitor and manage enterprise risks using an integrated approach. It combines all data related to risk management in one and comprehensive environment. This includes a reusable library containing risks and their corresponding controls, assessments, events like losses and non-conformities as well as key risk indicators, issues, and treatment plans. The risk heatmap feature allows organizations to prioritize and make strategic decisions based upon risk levels. The software is the foundation of enterprise risk management efforts for companies. It can unite and support different risk types such as financial, security, compliance, assets, products and processes, and it can also be used to support them.

RequirementONE is an advanced data platform that provides instant access to global regulatory advancements and serves as a collaborative space for digitalizing your processes and tasks. Enhance your productivity: By joining RequirementONE, you gain entry to a comprehensive platform equipped with all the tools necessary to confidently address regulatory changes. Tailor to your needs: Access regulatory updates from over 1000 regulators, industry organizations, and best practice sources in relevant jurisdictions. Take action on a single platform that covers all your informational and collaborative requirements. Efficiently analyze and prioritize changes: RequirementONE is the ultimate solution if you require fully translated regulatory updates across multiple regions. Our platform automatically routes them to you, ensures their actionability, and maintains a complete change history with extensive reporting capabilities. We simplify the process, allowing you to save up to 80% in costs and effort in no time. requirementone.com

You can easily adapt to changing regulatory requirements, and accommodate different interpretations of Basel II and III guidelines across multiple jurisdictions. Our flexible solution allows you to easily evolve your system so that you are always up-to-date. You can quickly get up to speed with regulatory compliance by using pre-defined regulatory environments, sample reporting and a banking-specific model. The parallel processing capabilities of SAS Infrastructure for Risk Management execution platform, which are integrated within SAS Risk Stratum, result in a reduction of 50% or more in processing time compared to previous versions. SAS Solution for Regulatory Risk management leverages the foundational capabilities from SAS Risk Stratum. This allows you to use your investment in multiple uses.

Axtria SalesIQTM is the most popular sales planning and operations software for the global life science industry. It enables motivated sales teams to achieve greater commercial success. Axtria SalesIQTM empowers sales reps to make smart decisions and reach the right customers at a time that suits their needs. Simulating and what-if analysis allows you to seamlessly convert brand strategy into sales plans. You can launch any drug or medical device in any therapeutic area quickly and with total flexibility. Transform from product-centric to customer centric omnichannel interactions. Connect the dots between providers and territories, channels, incentives, and incentives. You can improve decision-making by leveraging trusted data from ingestion to insights.

X-Fly, a leading insights-management platform, is designed specifically for teams in medical affairs and the life sciences. It offers an intuitive interface to streamline the process of capturing and analyzing critical insights, as well as sharing them. The platform allows users to enter unprompted free text, or survey-led insights, via any device, CRM or mobile app. Interactive and automated reporting tools are built-in, eliminating the need for complicated spreadsheets. This allows for efficient analysis and discovery patterns and emerging trends. X-Fly’s AI-powered copilot automates, enhances insight, and monitors new trends. This enables data-driven decisions. The platform is configurable and scalable, allowing it to be used by both small teams moving from Excel to large global enterprises. Its implementation process takes only two weeks. Security and compliance features are robust, ensuring data privacy in all markets. Granular controls support these features.