Alternatives to ClinChoice
Compare ClinChoice alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to ClinChoice in 2026. Compare features, ratings, user reviews, pricing, and more from ClinChoice 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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ClinCapture
ClinCapture
At ClinCapture our mission is to build software that saves lives. Our technology lowers the cost of clinical trials by streamlining data capture processes while providing a platform that protects patient privacy. Clincapture advances the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions. -
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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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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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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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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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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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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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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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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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Kalypso Accel for RIM
Kalypso
Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations. -
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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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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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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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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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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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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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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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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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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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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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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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Kivo
Kivo
Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.Starting Price: $1,800 per month -
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PharmaPendium
Elsevier
PharmaPendium is a comprehensive resource that provides access to FDA and EMA drug approval documents, including pharmacokinetic, pharmacodynamic, and safety profiles. It offers detailed information on drug-drug interactions, adverse effects, and clinical study outcomes, facilitating informed decision-making in drug development and regulatory submissions. The platform's extensive data supports researchers and healthcare professionals in evaluating drug efficacy and safety, contributing to the advancement of pharmaceutical research and patient care. Find information about previous regulatory submissions and profit from precedents to predict agencies’ requirements. Seamlessly move from table view to interactive charts, graphs, and visual aids to easily interrogate and interpret data. Find information by adverse events (MedDRA), targets, indications, drug,s and endpoints using normalized data. Result pages bridge the preclinical to clinical divide. -
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RAMS
Emergo by UL
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance. -
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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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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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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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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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ClinAccess
MAJARO InfoSystems
ClinAccess™ 5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SAS® 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SAS® data sets enhances your staff’s productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess™ is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SAS®and ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccess™. -
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Thrana Safety Database
Thrana Softech
Thrana Safety Database, a cloud-based pharmacovigilance and drug safetysystem. Designed with user-friendliness in mind, this end-to-end solution seamlessly integrates key functionalities such as PV Intake, Case Processing,Regulatory Submissions (AS2 Gateways),Regulatory Reports, and Analytics—allaccessible from a centralized platform.Starting Price: $17000 USD/year -
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DrugCard
DrugCard
DrugCard is an AI-powered pharmacovigilance platform that helps pharmaceutical companies, CROs, and drug safety teams automate key PV workflows. The platform supports global and local literature monitoring, regulatory intelligence, and adverse event management, helping teams reduce manual screening, identify relevant safety information faster, and maintain audit-ready processes. DrugCard combines AI-driven article pre-assessment, summaries, translations, keyword highlighting, notifications, reporting, audit trails, and case management tools in one connected system. With coverage of 121+ countries, 2,200+ local medical sources, and 100+ languages, DrugCard is designed for MAHs, QPPVs, LQPPVs, regulatory teams, and PV professionals who need scalable, transparent, and compliant automation while keeping human experts in control of final decisions.Starting Price: individual -
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LARVOL CLIN
LARVOL
The LARVOL CLIN platform delivers comprehensive, AI-powered data intelligence and analytics tailored for oncology and drug-development professionals by aggregating more than 100,000 cancer clinical trials along with detailed results, digitized Kaplan-Meier curves and forest plots, and real-time social-media reactions from over 5,000 oncologists. Users can search by condition, intervention, or trial ID within a single streamlined interface offering expert-curated insights and visual dashboards for data-driven decision-making. The system also covers conference tracking, biomarker and diagnostics databases, and market-intelligence reports from over 25,000 sources, including regulatory communications, clinical-trial registries, and scientific congresses. Built to support pharma and biotech teams in understanding trial outcomes, trends, mechanisms of action, biomarkers, and disease pipelines, the platform integrates deep search filters, heat-maps, real-time alerts, and more. -
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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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Citeline
Citeline
Citeline is a clinical development intelligence and analytics platform that provides real-time R&D data, insights, and tools to life sciences organizations to inform strategic decisions across the drug and device development life cycle. It aggregates and curates the world’s most extensive datasets on global clinical trials, investigators, trial sites, drug development pipelines, and regulatory requirements, supporting functions such as protocol design, feasibility analysis, site and investigator selection, enrollment forecasting, competitive benchmarking, and compliance tracking with disclosure obligations across jurisdictions. It includes products like Pharmaprojects for pipeline monitoring, Trialtrove for clinical trial benchmarking, Sitetrove for site/investigator intelligence, Global Patient Insights for aligning feasibility with real patient access, and TrialScope Intelligence/Disclose for managing regulatory disclosure requirements. -
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Clienvo eTMF
Clinevo
Clinevo electronic Trial Master File (eTMF) is an easy-to-use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has an inbuilt DIA reference model and meets regulatory guidelines. Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs). Clinevo Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform. Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface. -
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Saama
Saama
Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter. -
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AmpleLogic APQR
AmpleLogic
Introducing AmpleLogic AI-based APQR software, a revolutionary solution that helps you generate accurate Product Quality Review (PQR) reports and CPV reports for audits and regulatory submissions as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). With OCR data extraction and AI chatbot integration, AmpleLogic APQR solution streamlines document data extraction and quickens access to information, boosting audit readiness and operational efficiency. -
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Simulations Plus
Simulations Plus
Our reputation as thought leaders in the areas of ADMET property prediction, physiologically-based pharmacokinetics (PBPK) modeling, pharmacometrics, and quantitative systems pharmacology/toxicology is earned through the success our clients have found through their relationship with us. We have the talent and 20+ years of experience to translate science into user-friendly software and provide expert consulting supporting drug discovery, clinical development research, and regulatory submissions. -
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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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Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.
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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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CINCO
Cinco
A web based software that uses Quality Risk Management to organize, analyze and trace Quality information directly to the specific risk it represents to the patient and drug product. Why Us? CINCO, a risk-based quality management software for the Life Sciences Industry. It provides paperless traceability of every critical to quality aspect of a drug or medical device to enable transparent quality decisions at every moment. Why Risk Management? Quality Risk Management is methodology that provides an objective approach into identifying and mitigating the risks of a drug or medical device manufacturing process. It is currently required by most regulatory agencies. However, the paper-based approach the Life Sciences Industry currently uses its ineffective in managing the significant and valuable risk data. It is prone to errors, introduces too much friction to the users and ends up not adding the potential value to the operations. On-demand access to what is critical to the product qua -
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LifeSphere Medical Affairs
ArisGlobal
LifeSphere Medical Affairs is a cloud-based platform developed by ArisGlobal to enhance efficiency, compliance, and collaboration within medical affairs teams. It offers a unified workspace that seamlessly integrates medical information management with safety and quality systems, enabling end-to-end automation and real-time data sharing. The platform streamlines the intake and management of medical inquiries across multiple channels, automates the processing of product complaints and adverse events, and ensures consistent global compliance with evolving regulatory requirements. Its advanced analytics and reporting tools provide actionable insights, facilitating data-driven decision-making and improved patient outcomes. LifeSphere Medical Affairs is designed to be scalable and configurable, catering to the unique needs of organizations of all sizes. -
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RQM+
RQM+
RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models. -
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Beaconcure
Beaconcure
Intelligent clinical data analysis. Accelerate and de-risk regulatory approvals with our automated analytics and validation platform. The clinical data analytics software unlike no other improve data quality & de-risk your submission. Automate your manual quality process, Avoid QC rerun, Eliminate data duplication or inconsistencies, Ensure data traceability, Transparent quality process. Accelerate time to market & generate revenue earlier. reduce data validation time. free up resources, reduce cost. Accelerate regulatory approval. The need for accurate clinical data validation and high-quality data output has never been more urgent. Verify manages and analyzes clinical data to mitigate risk and expedite approval of a new drug and vaccine. Ensure quality, speed & success. -
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Signant Health
Signant Health
Signant Health is a global evidence-generation company that helps modernize clinical trials by meeting patients where they are and reimagining the path to proof. They offer comprehensive clinical technology solutions, including electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician ratings, and a unified eClinical platform. Their patient engagement tools encompass a patient engagement app, eConsent, and telemedicine capabilities. Signant Health also provides clinical data and analytics services, such as COA data analytics and data aggregation and intelligence. With over 30 years of experience, they have supported thousands of trials and contributed to hundreds of drug approvals, making them a trusted partner for sponsors and CROs aiming to deliver high-quality data for trial decisions and regulatory submissions. -
49
VerifyRX
LexisNexis
VerifyRx is a real-time, compliance-driven prescriber verification solution, designed specifically for pharmacies and PBMs, that seamlessly integrates into existing workflows. VerifyRx processes millions of transactions a day, updating comprehensive prescriber data in real-time, including Drug Enforcement Administration (DEA) and State data (when available) and daily National Technical Information Service (NTIS) data. As part of the pharmacy workflow, VerifyRx processes millions of transactions a day, updating comprehensive prescriber data in real-time, including Drug Enforcement Administration (DEA) and State data (when available) and daily National Technical Information Service (NTIS) data. The highly configurable and responsive tool provides real-time compliance checks on all prescription transactions before they are transmitted to payers, helping retail and specialty pharmacy reduce regulatory risk. It identifies potential claims submission errors prior to dispensation. -
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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.