Regulatory Affairs

Compare 139 regulatory affairs tools to find the right one for your needs

📂 Subcategories

🔧 Tools

Compare and find the best regulatory affairs for your needs

Kivo RIM

Simple, Compliant, Affordable RIM Software.

A cloud-based RIM system for small to mid-sized life sciences organizations.

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Drata

Automate your security and compliance, not just check the box.

A security and compliance automation platform.

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Kivo

Unified Regulatory, Quality, and Clinical for Life Sciences.

A cloud-based solution for small to mid-sized life sciences organizations, offering integrated RIM, QMS, and clinical capabilities.

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Generis CARA

The data and content management platform for regulated industries.

A unified platform for managing content, data, and business processes like RIM and QMS.

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Artwork Flow

AI-powered creative operations platform for fast-growing brands.

A cloud-based platform for managing creative projects, including artwork, labels, and packaging.

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AuditBoard

The Connected Risk Platform.

A cloud-based platform for audit, risk, and compliance management.

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Onspring

No-code GRC software that connects your teams, data and processes.

A no-code platform for GRC and business process automation.

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Rimsys

The Regulatory Information Management (RIM) Platform for MedTech.

A holistic RIM software platform designed specifically for the medical device industry.

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AuditBoard

The Connected Risk Platform.

A cloud-based platform for audit, risk, and compliance management.

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Qualio

The trusted eQMS for life sciences.

A cloud-based electronic quality management system (eQMS) for life sciences companies.

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Dot Compliance

AI-powered eQMS for Life Sciences Quality Management.

An AI-powered eQMS solution built natively on the Salesforce platform, offering ready-to-deploy quality and compliance processes.

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Rimsys

The first and only holistic RIM software for MedTech.

A Regulatory Information Management (RIM) platform built by and for medical technology regulatory professionals.

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Schlafender Hase TVT

The Text Verification Tool for regulated industries.

A software tool for automated proofreading of text and graphics in regulated documents, primarily for labeling and packaging.

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Rimsys

The first and only holistic RIM software for MedTech.

A Regulatory Information Management (RIM) platform built exclusively for medical devices.

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Specright

The First Purpose-Built Platform for Specification Management.

A cloud-based platform for managing all specification data, from raw materials to finished goods.

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Qualio

The trusted eQMS for life sciences.

A cloud-based electronic quality management system (eQMS) for life sciences companies.

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Generis CARA Life Sciences Platform

A comprehensive data and content management platform.

A platform for managing structured and unstructured data and content for regulated industries, including RIM, QMS, and clinical.

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ManageArtworks

Packaging Artwork Management Simplified.

A cloud-based packaging and artwork lifecycle management system for regulated industries.

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LogicGate Risk Cloud

The GRC platform that's as agile as you are.

A no-code platform for governance, risk, and compliance (GRC) process automation.

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Workiva

The World's Only Unified Platform for Assurance.

A cloud platform for reporting, ESG, audit, and risk.

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Hyperproof

Compliance Operations, Simplified.

A compliance operations platform for managing security and privacy compliance.

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VComply

The new standard in GRC.

A cloud-based platform for governance, risk, and compliance (GRC) management.

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Diligent

The GRC Platform for Leaders.

A GRC platform for boards and leadership.

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Generis CARA

The data and content management platform for regulated industries.

A unified platform for managing content and data in regulated industries, including RIM.

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AmpleLogic

Low Code No Code Platform for Pharma.

A low-code/no-code platform for building quality and compliance applications for the pharmaceutical industry.

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LogicGate Risk Cloud

The Risk Cloud® platform.

A no-code platform for governance, risk, and compliance (GRC).

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EXTEDOpulse

The complete RIM solution.

A comprehensive RIM software solution for the pharmaceutical and life sciences industry.

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ComplianceQuest

The #1 Salesforce Native Quality, Safety, and Compliance Platform.

An EQMS built on the Salesforce platform, with solutions for regulatory compliance.

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Parexel Lorenz docuBridge

The world's most advanced eSubmission production and management system.

An advanced electronic submission management system for compiling, publishing, and reviewing regulatory dossiers like eCTD.

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Montrium RIM

Centralize and manage your global product portfolio.

A cloud-based RIM platform designed to help emerging life sciences companies manage their regulatory information and submissions.

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Freyr iReady

A modular, data-driven RIM system built on ISO IDMP standards.

A RIM solution that enables effective management of product registrations, marketing authorization lifecycles, and regulatory documents.

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Ennov RIM

Your Single Authoritative Source of Regulatory Information.

A process-driven RIM solution for managing product portfolios worldwide.

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Montrium Regulatory Navigator

Take control of your regulatory documents and submissions.

A solution for managing regulatory documents and submissions within a regulated content management system.

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DocuSign for Life Sciences

Accelerate drug development with 21 CFR Part 11 compliant electronic signatures.

A solution for compliant electronic signatures and agreements in the life sciences.

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ComplianceQuest

The #1 Salesforce Native EQMS, EHS, and QMS Software.

A modern EQMS, EHS, and QMS platform built on the Salesforce platform.

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TransPerfect Trial Interactive

NA

An e-clinical technology solution that includes eTMF and other study management tools.

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TEKLYNX CENTRAL

Centralized Barcode Labeling Software Solution.

A browser-based, centralized label management system for creating, approving, and printing labels.

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BarTender

The Global Standard in Labeling, Barcode, RFID & Card Printing Software.

Software to create and automate the printing of labels, barcodes, and RFID tags.

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Veeva Vault PromoMats

Compliant Commercial Content and Digital Asset Management.

A cloud-based application for managing the entire lifecycle of promotional content in the life sciences industry.

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Ideagen

The best-in-class software for regulated industries.

Provides a suite of software solutions for GRC, including quality, safety, audit, and risk management.

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Veeva Vault

The Industry Cloud for Life Sciences.

A cloud platform for the life sciences industry, including regulatory, quality, and clinical solutions.

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Resolver

Transform risk into risk intelligence.

A GRC platform for managing risk, compliance, and incidents.

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OneTrust

The Trust Intelligence Platform.

A platform for privacy, security, and governance.

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NAVEX

The global leader in integrated risk and compliance management.

A platform for risk, compliance, and ethics management.

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ZenGRC by RiskOptics

See. Understand. and Manage Cyber Risk.

A GRC platform for managing risk and compliance.

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ServiceNow GRC

Transform risk into reward.

A GRC solution built on the ServiceNow platform.

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EXTEDO RIM ONE

A comprehensive RIM software solution for every step of pharmaceutical product development.

A modular RIM platform consisting of five hubs that can be used individually or together to manage the regulatory lifecycle.

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SAI360

The Leading GRC Cloud Platform.

A cloud-based platform for managing risk, compliance, and ethics.

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ETQ Reliance

The leading QMS, EHS, and compliance management software.

A quality management, EHS, and compliance platform.

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Qualys

The TruRisk Platform.

A cloud platform for IT, security, and compliance.

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Ennov RIM

Unified Regulatory Information Management.

A comprehensive RIM software solution for managing global regulatory information.

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SAP S/4HANA for product compliance

Manage product compliance and sustainability.

An enterprise solution for managing product compliance, including regulatory requirements.

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ETQ Reliance

The QMS that makes you stronger.

A flexible and scalable quality management system (QMS) with regulatory compliance features.

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MetricStream

The Global Market Leader in Integrated Risk Management and GRC.

A comprehensive GRC platform with solutions for regulatory compliance.

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Veeva Vault RIM Suite

Unified RIM to streamline global regulatory processes.

A cloud-based platform for managing regulatory submissions, product registrations, and health authority interactions.

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MasterControl Regulatory Excellence

Keeps your product reviews, approval and release on track.

Connects the entire product development lifecycle, ensuring regulatory compliance from conception to commercialization.

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Veeva Vault RIM

A unified suite of applications to manage the end-to-end regulatory lifecycle.

Cloud-based Regulatory Information Management (RIM) suite for the life sciences industry.

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MasterControl Regulatory Excellence

Accelerate your speed to market with a full-featured RIM software solution.

An integrated solution for managing submissions, registrations, and regulatory data.

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Veeva Vault Submissions

A single, global authoritative source for submissions.

Part of the Veeva Vault RIM Suite, it provides a single source for all submission documents and data.

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MasterControl eCTD Publishing

Streamline Your eCTD Publishing Process.

An eCTD publishing solution that integrates with a comprehensive quality management system.

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Loftware Spectrum

Enterprise Labeling and Artwork Management.

A comprehensive solution for designing, managing, and printing labels and artwork across the supply chain.

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MetricStream

Turn Risk Intelligence into Action, Enhance Operational Efficiency.

An integrated Governance, Risk, and Compliance (GRC) platform that helps organizations manage risk and ensure regulatory compliance.

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MasterControl

The only platform life science leaders trust for integrated quality, manufacturing, and asset management.

Provides quality management software (QMS) to help regulated companies streamline compliance and get products to market faster.

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MetricStream

The Global Leader in Integrated Risk Management and GRC.

An enterprise platform for Governance, Risk, and Compliance (GRC) and Integrated Risk Management (IRM).

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MasterControl

The #1 QMS for Life Sciences.

A quality management system (QMS) for regulated industries.

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Archer

The Leader in Integrated Risk Management.

An integrated risk management (IRM) platform.

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Veeva Vault RIM

A unified suite of applications to streamline global regulatory processes.

Cloud-based regulatory information management (RIM) software for the life sciences industry.

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MasterControl Regulatory Excellence

Automated Regulatory Submission Management.

A solution that automates and streamlines regulatory submission processes.

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ArisGlobal LifeSphere RIM

An innovative, end-to-end approach for pharmaceutical regulatory affairs.

A SaaS-based RIMS solution that uses a process-based approach for tracking and managing all regulatory affairs submissions.

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Calyx RIM

Manage and track regulatory information with confidence.

A proven, scalable RIM system for managing and tracking all regulatory information, from clinical applications to post-market activities.

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Esko WebCenter

Packaging Management, Simplified.

A web-based platform for managing the packaging pre-production process, including specifications, approval, and project lifecycle.

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SAP GRC

Govern your enterprise, manage risk, and ensure compliance.

A suite of solutions for governance, risk, and compliance from SAP.

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ArisGlobal LifeSphere RIM

The End-to-End Platform for Regulatory Affairs.

A unified, cloud-based platform for managing the entire regulatory lifecycle.

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Oracle Argus Safety

The leading pharmacovigilance and safety database.

A comprehensive platform for managing drug safety and pharmacovigilance, with regulatory reporting capabilities.

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Trace One

The world's largest collaborative platform for retail and CPG.

A platform for product lifecycle management (PLM) and compliance for the retail and CPG industries.

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IQVIA RIM Smart

Intelligent, end-to-end management of the complete regulatory lifecycle.

A fully integrated, technology-led platform for managing the complete regulatory lifecycle, from submission to post-market surveillance.

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Ennov RIM

Purpose-built for the management and tracking of therapeutic product details and registration information.

A modular RIM solution that supports the end-to-end regulatory lifecycle, from submission tracking to registration updates.

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OpenText Documentum for Life Sciences

Ensure GxP-compliant content management in life sciences.

A comprehensive, purpose-built solution for managing regulated content.

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ArisGlobal LifeSphere Labeling

Streamline your labeling workflows through end-to-end labeling change management and compliance tracking.

A solution for managing the entire labeling lifecycle, from core data sheet to final label.

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BLUE Software

Labeling and Artwork Management Software.

A solution for managing the development and approval of labeling and packaging artwork.

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IQVIA RIM Smart

The intelligent way to manage regulatory information.

An end-to-end regulatory information management platform for the life sciences industry.

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OpenText Documentum for Life Sciences

Accelerate innovation and navigate the digital future of life sciences.

Content management solutions to control all content, including documents, images, and email, related to clinical, quality, and regulatory.

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TrackWise Digital

The industry's leading AI-enabled EQMS.

A cloud-based Quality Management System (QMS) with regulatory management capabilities.

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TrackWise Digital (Sparta Systems)

The industry's leading cloud QMS, now even smarter with AI.

A cloud-based Quality Management System (QMS) built on the Salesforce platform for managing quality and compliance.

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Sparta Systems - TrackWise Digital

A Honeywell Company. The Leader in Enterprise Quality Management.

An enterprise quality management software (EQMS) for regulated industries.

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Sparta Systems TrackWise Digital

The Foundation for Digital Quality.

A cloud-based enterprise quality management software (QMS) with regulatory management capabilities.

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Sparta Systems TrackWise Digital

Cloud-based quality management system with integrated modules for quality and compliance.

A leading QMS platform that helps life sciences companies manage quality, compliance, and regulatory processes.

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Instem Samarind RMS

An intelligent solution for overseeing your medical product information more effectively.

A RIM system where data is entered once and reused across submissions, renewals, variations, and other regulatory activities.

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Amplexor Life Sciences Suite

Manage enterprise regulated content and processes.

A suite of tools to manage regulated content and processes, helping clients achieve and maintain global regulatory compliance.

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Phlexglobal PhlexRIM

The industry's first intelligent RIM software powered by regulatory experts.

A complete, end-to-end RIM platform that automates the management of product and registration information.

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DDi ViSU

End-to-End Regulatory Information Management (RIM) platform for the medical device industry.

A cloud-based RIM platform for medical device companies to manage regulatory data, dossiers, submissions, and compliance.

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Veratrak

The Collaboration Platform for the Pharmaceutical Supply Chain.

A platform for secure document collaboration and data exchange between pharmaceutical companies and their supply chain partners.

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IQVIA RIM Smart

Intelligent management of the complete regulatory lifecycle.

An end-to-end regulatory information management system for pharma and MedTech.

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LORENZ docuBridge

Regulatory publishing and content management for everyone.

An advanced electronic submission management and publishing system.

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ArisGlobal LifeSphere RIM

The industry's most complete, unified, and user-friendly regulatory platform.

A unified, cloud-based platform for end-to-end regulatory information management.

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Freyr rDMS

Transform Document Management into a Strategic Advantage.

An intelligent platform for regulatory document management and compliance.

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EXTEDOpulse

The complete Regulatory Information Management platform.

A comprehensive RIM software solution consisting of five interconnected hubs.

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AmpleLogic RIMS

Best Regulatory Information Management System (RIMS) 2025.

A low-code RIM system to streamline product application and registration.

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DDi ViSU

Cloud based End-to-End Regulatory Information Management (RIM) platform.

A cloud-based RIM platform designed specifically for the medical device industry.

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Instem SUBMIT

A comprehensive suite of integrated tools and services for the creation, management and submission of SEND data.

A suite of tools focused on creating and managing SEND datasets for regulatory submissions.

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Phlexglobal PhlexRIM

The next generation of regulatory information management.

A modular RIM software for planning, tracking, and managing regulatory activities.

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Samarind RMS

The Smarter Regulatory Management System.

A modular software solution for managing regulatory information and processes.

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Calymantra eCTD Express

A cost-effective and user-friendly eCTD publishing software.

A desktop eCTD publishing tool designed for affordability and ease of use.

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Freyr SUBMIT PRO

Be Proactive. Be Productive. Be a Pro in Submissions.

A cloud-based eCTD submission software for the life sciences industry.

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GlobalSubmit PUBLISH

Create health authority compliant eCTD submissions quickly and accurately.

eCTD publishing software for creating and submitting compliant regulatory submissions.

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EXTEDOpulse

The next generation of Regulatory Information Management.

A comprehensive RIM software solution for the life sciences industry.

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LORENZ docuBridge

The most established eCTD submission management system.

An advanced electronic submission management system for compiling, publishing, and reviewing regulatory submissions.

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PhlexSubmission

Compliant. Fast. Successful.

A robust and configurable publishing engine for electronic submissions.

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pharmaREADY

Empowering Innovation through Regulatory Excellence.

A fully integrated, regulatory compliant, web-based platform for global regulatory submissions.

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Ennov Dossier

Effortlessly build, manage, and publish regulatory dossiers.

A regulatory submission publishing software that is integrated with a comprehensive EDMS.

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Samarind eCTD

NA

An eCTD submission management tool for the pharmaceutical industry.

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Glemser eCTD

NA

Provides solutions for regulatory compliance, including eCTD submissions.

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e-Submissions Manager

NA

A software for managing electronic submissions.

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Cuneso eCTD

NA

Offers services and solutions for eCTD submissions.

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DocuSharen D2

NA

A platform for secure document sharing and collaboration, with applications in regulatory submissions.

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Amplexor myProcess

NA

A suite of solutions for content management and regulatory compliance.

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NextGen eCTD

The ultimate solution for your regulatory submission needs.

A comprehensive software solution for creating, managing, and publishing eCTD submissions.

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Ziva DRA

Revolutionary eCTD Software: 1 Solution for Fast Compliance.

An eCTD software tool for preparing, validating, and submitting electronic regulatory content.

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Artixio eCTD Publishing

Trusted Partner for eCTD Submissions.

Provides comprehensive regulatory operation services for eCTD and NeeS submissions.

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Mono eCTD Office

NA

An eCTD software tool for electronic submissions.

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Educe Solution

NA

A provider of eCTD software solutions.

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RIM INSIGHTS

NA

An eCTD software tool.

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Please+Publish

NA

An eCTD publishing software that automates formatting and enhances quality control.

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Kallik Veraciti

End-to-end enterprise labeling and artwork management software for highly regulated industries.

A cloud-native platform providing a single source of truth for product packaging and labeling assets.

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Freyr LABEL 360

Comprehensive Label Life Cycle Management Tool.

A tool to manage label changes globally in a streamlined and timely manner.

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Perigord GLAMS

Global Artwork Management System.

A web-based artwork management solution for the life sciences industry.

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Innovatum ROBAR

Enterprise Labeling for Life Sciences.

An enterprise label management system for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.

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Loftware PRISYM 360

The proven solution for clinical trial supply labeling.

A validation-ready, cloud-based label printing platform for the clinical trials industry.

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Redica Systems

The Intelligence Cloud for quality and regulatory operations, transforming regulatory complexity into trusted, proactive intelligence.

Unifies global regulatory intelligence, inspection data, and supplier insights to predict and prevent compliance risks.

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IQVIA RIM Smart

Intelligent management of the complete regulatory lifecycle.

An end-to-end Regulatory Information Management (RIM) system for life sciences to manage the full product lifecycle.

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RegDesk

The one-stop solution for medical device regulatory compliance.

An AI-powered RIMS platform for medical device, pharma, and IVD firms that streamlines global compliance and automates submissions.

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Thomson Reuters Regulatory Intelligence

Anticipate and manage global regulatory developments in a single solution.

A comprehensive solution for managing regulatory risk by tracking global developments and mapping obligations to internal controls.

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Compliance.ai

Regulatory Change Management, Perfected.

An AI-powered platform that monitors, analyzes, and maps regulatory changes to internal policies and controls.

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AmpleLogic

Delivering compliant, transformative solutions for Life Sciences.

Provides a suite of GMP-compliant software solutions for the pharmaceutical industry, including QMS, DMS, and LMS.

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Freyr rDMS

A Compliant Document Management System.

A regulatory document management system for the life sciences industry.

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RegDesk

AI-Powered Regulatory Automation.

An AI-powered platform for managing regulatory submissions and intelligence.

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Samarind RMS

The complete Regulatory Management System for the Life Science Industry.

A comprehensive software solution for managing regulatory information and processes.

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CUBE

Automated Regulatory Intelligence.

An AI-powered platform for automated regulatory intelligence and change management.

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Coptis

Cosmetic R&D Software Solutions.

A software solution for managing cosmetic formulation, testing, and regulatory compliance.

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