Alternatives to Kalypso Accel for RIM
Compare Kalypso Accel for RIM alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Kalypso Accel for RIM in 2026. Compare features, ratings, user reviews, pricing, and more from Kalypso Accel for RIM competitors and alternatives in order to make an informed decision for your business.
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RegDesk
RegDesk
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website. -
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Veeva CRM
Veeva Systems
Trusted by the global life sciences industry to drive intelligent engagement. Improve customer experience with intelligent HCP engagement in real-time across all channels. Leverage data science and embedded intelligence to deliver the most effective, timely messages to customers. Ensure field teams have the most up-to-date information and insights to plan and execute calls. Build deeper customer relationships with compliant note capture. Tailored insights at the point of execution via pre-built and custom visualizations. Veeva CRM provides flexibility for commercial organizations to implement artificial intelligence how they want. Veeva CRM Suggestions provides an open model to implement next best actions using any data science provider. -
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Veeva Vault RIM
Veeva
End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps. -
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Ennov RIM
Ennov
Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide. -
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RIMTrack
WinWire Technologies
With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process. -
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Essenvia
Essenvia
Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country. -
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KnowledgeNET
Sarjen Systems
Sarjen's global dossier publishing software is a platform designed to simplify and automate the management and submission of regulatory dossiers. It streamlines the regulatory submission process by automating region-specific and product-specific workflows, which enhances consistency, efficiency, and accuracy. This automation helps to accelerate the creation, validation, and submission of dossiers, reducing manual errors and compliance issues. The solution is built to improve operational efficiency, maintain data consistency, and ensure documentation is audit-ready. By doing so, it saves time and facilitates faster regulatory approvals, ultimately helping to ensure submissions are compliant with various global requirements.Starting Price: $200 -
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LifeSphere RIMS
ArisGlobal
Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. -
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ProcEdge RIMS
Sarjen Systems Pvt Ltd
ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.Starting Price: $300 -
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LICENSALE
Arazy Group
All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets. -
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Redica
Redica Systems
Redica is an intelligence cloud platform designed to support quality and regulatory teams within life sciences organizations. It transforms complex global regulatory data into clear, actionable intelligence that helps teams stay compliant and proactive. The platform unifies regulatory intelligence, inspection findings, and supplier quality insights into a single connected system. By using explainable AI, Redica enables teams to monitor regulatory changes and understand their impact faster. Its inspection intelligence tools help organizations predict and prepare for audits using global benchmarking data. Redica also provides site and supplier intelligence to manage manufacturing and supply chain risks effectively. Overall, the platform shifts teams away from manual data tracking toward faster, insight-driven compliance decisions. -
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ViSU
DDi
ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control. ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction. -
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ClinChoice
ClinChoice
ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices. ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in regulatory information management system (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in the management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have visibility and tracking of all regulatory information. With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations. -
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Samarind RMS
Instem
Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™. -
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Rimsys
Rimsys Regulatory Management Software
Rimsys is bringing regulatory order to the medtech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys streamlines all regulatory activities including registrations, essential principles, UDI, standards management, and regulatory intelligence in a single, integrated platform. -
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OpenText for Life Sciences
OpenText
OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts. -
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Regislate
Arazy Group
Everything you need to successfully register your medical device or IVD product in any market around the world and manage your market access license through the product life cycle. REGISLATE® provides users with medical and IVD device-specific at country-specific complete submission file requirements. Users can manage milestones, timelines and estimated and actual completion dates for initial registrations, renewals, amendments and license transfers in real-time. Infographic data and proprietary indicators for clear monitoring and management of each project are available. Utilize collaboration tools for preparation and review of submissions, compliance requirements and documents. Recieve progress reports in real-time for current and future submissions including market access readiness index. REGISLATE® includes GR-MAP registration tracking for both country and product. -
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RegDocs Connect
Montrium
RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content -
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PhlexRIM
Phlexglobal
PhlexRIM will dramatically improve compliance with efficient and effective real-time access to your global registration information. PhlexRIM 2.0 contains a library of pre-configured automation assistants, or “bots,” as well as built-in regulatory use cases based on industry best practices. Utilizing an intuitive drag-and-drop design tool, regulatory teams can automate their business processes without programming knowledge or IT support. Manage the lifecycle of pharmaceutical product registration activities. Get extensive status information and use the alert management which is included in all workflows. Illustrate reports using standard reports or design your own reports. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates. -
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RIMExpert
AMPLEXOR
RIMExpert™ addresses regulatory planning, tracking and data management by managing the global rollout plans and automating the creation of regulatory applications, activities and medicinal products, RIMExpert™ reduces data entry needs, improving data quality and increasing global oversight and control. Standardize regulatory planning, tracking and registration management processes. Strengthen collaboration between headquarter(s) and affiliates. Create one common place to work in all registration activities. Having one access point to all activities, questions, commitments, correspondence and authorizations for every application. Synchronize efforts for maximum efficiency of enterprise regulatory resources. Control registration activities throughout the lifecycle of the product keeping abreast of timelines and status of commitments and agency questions. Interactive dashboards for actionable regulatory activities and registrations overview. -
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Bluenote
Bluenote
Bluenote is an agentic AI software designed to help life sciences companies accelerate their regulatory submissions and documentation workflows, boosting productivity by automating critical tasks with enterprise-grade security and proven accuracy. It generates first drafts of scientific, clinical, and regulatory documents instantly, aligned with templates, standard operating procedures, and global guidelines, with built-in verification and traceability. It includes an AI assistant to refine data presentations, format datasets and tables, write figure captions, and run gap analyses. Bluenote’s workflow builder and specialized agents automate repetitive, multi-step processes so scientists and subject matter experts can focus on innovation, and its search tools let users explore internal datasets quickly to surface insights and reduce duplication. It also offers translation of technical and regulatory content while preserving formatting and glossary use. -
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EXTEDOpulse
EXTEDO
EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individually or gain additional value by using them together based on your requirements. Developing pharmaceutical products can be a multi-faceted process, involving input and efforts from across an organization. The complexities of operating within a highly regulated industry only further compound the challenges that a life science organization faces with every release. Having our finger on the pulse of the life sciences anatomy allows us to provide you with great synergy, connection and innovation for effortless compliance. EXTEDOpulse has been designed with these aspects in mind to help you connecting the dots throughout the entire lifecycle of pharmaceutical products. EXTEDO understands the complexities of the regulated pharmaceutical product journey. -
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DXC RIM
DXC
DXC RIM platform manages regulatory affairs content, data, and workflows in one central location, helping teams accelerate innovation and reduce time to market. The sensitive nature of regulatory affairs (RA) content demands a unified platform to handle regulatory data and workflows. Teams need simple, always-ready access to all relevant data. They also require an intuitive, customizable user interface that is easy to navigate. Collaborative tools and configurable reporting are crucial for success, but legacy technology can frustrate teams and slow processes. Achieving compliance is a struggle. Collecting data and documenting processes is time-consuming. Problems are compounded when life sciences organizations run fragmented legacy systems using disparate technologies. In some cases, they need to resort to spreadsheets to manage key operational processes. Bringing products to market and managing RA requires a centralized, enterprise-grade solution. -
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Ennov Regulatory Suite
Ennov
Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning. -
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Regulatory functions hinge on high-cost contributors across a variety of regulatory content. A cloud-based offering like Infosys regulated document management platform is the perfect solution to this problem. Externalization, collaborative authoring and editing. Simplify governance, processes, and implement consumption-based commercial model; provide support for audit trails. Create custom workflows, and provide support for versioning; implement a proven solution with 99.95% guaranteed uptime in production. Our solution enabled business users to search documents from a vast repository within 3/4 seconds. The new system also offered users unlimited on-demand storage. The DMS uses Google application programming interfaces (APIs) to reduce operational and maintenance costs. The company’s overheads are limited to API usage and storage space.
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MediSpend
MediSpend
MediSpend is a global technology company providing best-in-class solutions that empower life sciences companies to grow their business compliantly through top-rated software and client services. Serving as the compliance system of record for some of the world's largest pharmaceutical, medical device, dental, and emerging biotech companies, MediSpend offers the global compliance suite, the industry's first global SaaS solution purpose-built to manage the end-to-end process of HCP/O engagement through transparency reporting. This suite includes the engagement manager, enabling businesses to plan, engage, and pay HCP/Os for activities that meet company objectives using embedded rules; the transparency solution, which automatically aggregates, validates, and reports transfers of value to comply with all global laws and codes; the funding management solution, tracking organizations' grants and funding requests from initial submission through post-event closeout. -
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IQVIA RIM Smart
IQVIA
Streamline your regulatory processes with our new, end-to-end regulatory information management system, IQVIA RIM Smart. Free your team from labor-intensive maintenance to focus on delivering valuable products to market. RIM Smart is the modern regulatory information management solution built to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost. Delivered securely in the cloud, IQVIA RIM Smart provides interconnected, comprehensive and intelligent management of the entire regulatory process. IQVIA safety and quality platform integration will heighten performance and enhance flexibility. Automate manual processes and increase connectivity for improved efficiency, cost savings, and better coordination and cross-enterprise visibility. -
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Freya
Freyr Solutions
Freya is an AI-powered chatbot designed to streamline the process of navigating complex global regulatory frameworks. It enables users to ask direct questions and receive prompt, accurate, and verified answers based on a comprehensive database of over 40,000 regulations across 150+ markets. Freya offers real-time access to regulatory updates, translations, and document summaries, making it easier for regulatory affairs teams to manage compliance. The platform is powered by over a decade of regulatory intelligence and integrates seamlessly with your existing systems, providing actionable insights and helping companies save time and reduce compliance risks. -
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Confluence
Confluence Technologies
Confluence Technologies is a global leader in data-driven investment management solutions, helping clients optimize efficiency and control across regulatory, analytics, and investor communications. Serving over 1,000 clients in 40 countries, including top asset managers and service providers, Confluence delivers products and services designed to streamline investment monitoring, risk management, and regulatory compliance. -
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Accruent Meridian
Accruent
Keep all your documents and drawings in one place with our top-performing enterprise document management software. Meridian provides a single source of truth, configurable workflows to streamline collaboration with all internal departments and ensures every document change is versioned and audited to demonstrate regulatory compliance. Engineering document management is the process of effectively searching for, finding and managing the complex engineering documents – including CAD files, drawings, designs, technical documents and communication documents, that exist in AEC organizations (Architecture, Engineering & Construction). Effective engineering document management can often be difficult for businesses in these industries. Meridian’s document management system for engineering projects can resolve these concerns. Meridian can centralize an organization’s relevant documents and drawings while automating key processes. -
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Dow Jones Risk & Compliance
Dow Jones Risk & Compliance
Dow Jones Risk & Compliance is a global provider of best-in-class risk data, web-based software applications and scalable due diligence services that help organizations manage risk and meet regulatory requirements related to financial crime, third-party risk management, sanctions and international trade. Built on the legacy of one of the world’s most trusted newsrooms, Dow Jones Risk & Compliance combines the expertise of a multilingual research team with industry-leading data scientists and technologists to provide actionable content structured specifically for compliance needs. Our solutions were developed in partnership with top legal and political advisors — including former regulators — to help our clients maintain consistency across global business units and teams. -
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Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
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MSLInsight
MSLInsight
MSLInsight is a cloud-based platform designed for Key Opinion Leader (KOL) interaction management, specifically tailored for nascent life sciences companies in the pharmaceutical, biotechnology, medical device, and diagnostics sectors. It integrates all KOL insights into a unified platform, enabling Medical Science Liaisons (MSLs) to improve productivity and manage interactions efficiently. The platform provides a real-time dashboard for monitoring KOL interaction data and ensures compliance with regulatory requirements. MSLInsight helps streamline workflows by allowing seamless data integration and mobile access, enabling MSLs to record, report, and analyze interactions from day one. It enhances product awareness and adoption by facilitating the flow of information between companies and the medical community, supporting regional, national, and global efforts. Built on the Salesforce platform, the software is easy to implement and use, providing an affordable solution for companies. -
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Axtria DataMAx
Axtria
Axtria DataMAx™ is the next-generation global cloud-based commercial Life Sciences data management product enabling accelerated actionable business insights from trusted data. Axtria DataMAx™ facilitates the rapid integration of all major structured and unstructured life sciences data sources, securely, accurately, and with industry compliance. Data quality and business management rules are applied to make sure the data being processed is conditioned for its intended use and can be trusted. Users can provision data mart creation for downstream consumption and reporting by analytics systems, models, or individual data stewards. -
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AccelSafety
Techsol Life Sciences
AccelSafety is a comprehensive pharmacovigilance platform developed by Techsol Life Sciences, built around the Oracle Argus Safety application to address the unified collection, medical assessment, and regulatory reporting of clinical and post-marketing safety surveillance data. The fully managed cloud solution facilitates emerging biopharma companies, device manufacturers, and service providers in managing safety data and making informed business decisions in alignment with global compliance requirements. Key benefits include fast-track Argus Safety implementation, migration, and validation with a 70% effort reduction; secure migration of legacy safety data to the AccelSafety Cloud; simplified lean case processing through customized configurations and native automation; comprehensive operational insights via advanced reports, line listings, and analytics packages; and 24/7 Argus Safety Service Desk support for user requests, incidents, and change management. -
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Flatiron Horizon
Flatiron
Flatiron Health's Evidence Solutions offer a flexible approach to generating both prospective and retrospective real-world evidence, empowering life sciences companies to achieve their oncology research goals more efficiently. Central to these solutions is Flatiron Horizon, which integrates a vast repository of over 5 million de-identified patient records and 1.5 billion data points, advanced curation methods, and disease-specific machine-learning models. This platform supports various stages of the biopharma lifecycle, including discovery, clinical study design, regulatory submissions, and post-marketing commitments. Flatiron's services encompass real-world data configurations tailored to specific oncology needs, prospective evidence generation through low-interventional studies, protocol optimization, patient identification, and seamless EHR-to-EDC data transfer via Flatiron Clinical Pipe. -
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RegMind
RegMind
RegMind is a smart regulatory intelligence platform built for the banking, finance, and insurance industries. It maintains a real-time inventory of global, European, and national regulations, sourcing data from authorities such as FATF, EU Commission, ECB, AMF, and more. With automated comparison tools, RegMind highlights changes between versions of texts, tracks parliamentary debates, and maps the full evolution of laws and directives. Users can set custom alerts, follow related guidelines and Q&As, and leverage a 360° view that shows how laws impact specific codes and articles. Teams can collaborate through shared folders and integrate research directly into Microsoft Teams. Its Smart Sanctions Analyser® module provides deep insights into sanctions from French and European regulators, helping organizations avoid compliance risks and penalties. -
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Infor PLM Optiva
Infor
Infor PLM for Process (Optiva®) is specifically designed for food, beverage, chemicals, and life science manufacturers and provides a unified product view of data and processes across organizations. It helps manufacturers easily achieve regulatory and labeling compliance, whether it’s meeting reporting requirements, complying with labeling laws, or supplying ingredient details. Project management capabilities give the right people the right visibility into project data, from concept, to development, to final sign-off. Reckitt Benckiser (RB), a British multinational consumer goods company, adopts modern PLM capabilities using Infor® PLM for Process to boost global safety and compliance and get one version of the truth about its products, from development to manufacturing. Integration capabilities with ERP systems helps provide better insight into costs. -
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ComplianceAuthor
Glemser Technologies
Glemser provides IT solutions for regulated industries with a focus on global life sciences and the ecosystem that improves patient outcomes. ComplianceAuthor makes it seamless for life science companies to manage global product labeling, provide affordable IDMP and reduce compliance risk. ComplianceAuthor for Global Labeling helps life science regulatory professionals manage, scale, and streamline global product labeling and compliance through artificial intelligence, structured content, and natural language generation. Artificial intelligence and machine learning to find, index and derive knowledge needed to recommend your next best course of action. Our workflow overlays provide innovation for process standardization, resulting in components that are compliant and controlled. Natural language generation enables you to adopt operational efficiencies and smarter automation. -
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THINQ Compliance
THINQ Compliance
As a thought leader in compliance for the Life Sciences industry, THINQ provides compliance solutions to a broad range of pharmaceutical, medical device and biotechnology companies. With a special expertise in validation, THINQ is now leading the way in changing how validation is managed in Life Sciences companies. THINQ offers comprehensive compliance program development and management—powerful market-proven solutions, custom-tailored for our enterprise clients. Transform governmental mandates into a competitive advantage!In today’s regulatory environment, forward-thinking organizations understand that compliance, risk mitigation and validation must not only be managed but mastered. With more than 20 years of market-proven compliance expertise and experience, THINQ Compliance can show your enterprise how to create and implement a risk-management and compliance solution. Experience the thrill of compliance training classes delivered by some of the brightest minds in the industry.Starting Price: $20000.00/one-time -
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GlobalSubmit
Certara
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions. -
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cubeSAFETY
CRScube
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead. -
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Axtria SalesIQ
Axtria
Axtria SalesIQ™ is the leading sales planning and operations solution for the global life sciences industry that enables effective and motivated sales teams resulting in higher commercial success. With the sales rep role continually evolving to meet the demands of a complex commercial model, Axtria SalesIQTM empowers them to make intelligent decisions and reach the right customers at the right time with flexibility and agility. Seamlessly convert brand strategy into concrete sales plans through simulation and what-if analysis. Accelerate the launch of any drug or medical device for any therapeutic area with complete flexibility. Move from product-centric to customer-centric omnichannel interactions and engagement. Connect the dots between providers, territories, channels, and incentives. Strengthen decision making by leveraging clean, trusted data, from ingestion to insights. -
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AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.
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FactoryTalk PharmaSuite
Rockwell Automation
FactoryTalk® PharmaSuite is the leading MES solution developed specifically for the Life Sciences industry. It provides role-based optimization of each stage of the recipe life cycle and drives time to results for all users. Its open-content architecture paired with an intelligent upgrade engine provides a powerful system for growth in both batch and discrete processing. Our FactoryTalk PharmaSuite MES provides value-based applications to help you adhere to regulatory compliance guidelines. MES also helps you achieve operational excellence, increase the effectiveness of your supply chain, and meet your sustainability goals. PharmaSuite MES provides production operations management to help you meet regulatory compliance, achieve operational excellence, increase supply chain effectiveness, and meet your goals. Optimize production, speed time-to-market, and ease compliance with a modern MES. -
46
Medidata
Dassault Systèmes
The Medidata Clinical Cloud is our cutting-edge platform that transforms the clinical trial experience for patients, sponsors, CROs, and research sites. As the only unified technology platform dedicated to clinical research, the Medidata clinical cloud addresses the holistic research process from start to finish. Our platform helps life science and medical device organizations cut development costs, mitigate risks, and deliver treatments and devices to market faster. No matter which products you choose for your clinical trial program, you will have access to the power of the Medidata Clinical Cloud. At Medidata, we’re leading the digital transformation of clinical research. Powered by artificial intelligence, machine learning and advanced analytics, our platform brings researchers, study managers, investigators, and patients together to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials. -
47
Incentivizer
Incentivizer.ai
Incentivizer is a B2B SaaS platform for managing end-to-end channel incentive programs. It centralises the entire lifecycle—from participant registration and claim submission to automated approvals and reward fulfilment—into a single system. Key Features: *Diverse Incentives: Supports deal registration, sales accelerators, training, renewals, and marketing activities. *Automation: Streamlines claim validation, approval workflows, and notifications to reduce manual effort. *Rewards & Reporting: Offers global digital rewards and real-time dashboards for tracking performance and ROI. *Security: Features role-based access and 2FA to ensure compliance. Designed for scalability, Incentivizer handles everything from tactical promos to global, multi-tier programs. It simplifies complex channel operations while providing the data needed to drive partner performance.Starting Price: £875 per month -
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Agatha
Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11. -
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Datatrak
Datatrak International, Inc.
Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak’s unified eClinical solutions and related services help improve cost and time efficiencies for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via Datatrak’s Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. Our commitment is to empower workgroup teams with role-based access to version-controlled file management, calendar events, tasks and contacts, all built within our eClinical applications including EDC, CTMS, reporting, data analytics and business intelligence. -
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Pepper Flow
Vodori
Pepper Flow’s unique features are built specifically to help life science companies streamline how marketing, medical, legal, and regulatory professionals work together. As a marketer, you need tools that allow you to move fast and keep things simple during advertising and promotional reviews. Get your critical campaigns and content to market to support your organization’s strategic initiatives. Maximize productivity by collaborating in real time to address feedback and turn around revisions. Spend less time managing the review process and more time on your high-priority to-dos. Pepper Flow is cloud-based, enterprise-grade software that enables life science companies to improve their competitive advantage, market products with efficiency, and maintain rigorous compliance. You need to move fast in order to deliver content to your key audiences. Pepper Flow’s intuitive interface allows you to get work done quickly and effectively.
