Regulatory Affairs
Compare 139 regulatory affairs tools to find the right one for your needs
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🔧 Tools
Compare and find the best regulatory affairs for your needs
Kivo RIM
A cloud-based RIM system for small to mid-sized life sciences organizations.
Drata
A security and compliance automation platform.
Kivo
A cloud-based solution for small to mid-sized life sciences organizations, offering integrated RIM, QMS, and clinical capabilities.
Generis CARA
A unified platform for managing content, data, and business processes like RIM and QMS.
Artwork Flow
A cloud-based platform for managing creative projects, including artwork, labels, and packaging.
AuditBoard
A cloud-based platform for audit, risk, and compliance management.
Onspring
A no-code platform for GRC and business process automation.
Rimsys
A holistic RIM software platform designed specifically for the medical device industry.
AuditBoard
A cloud-based platform for audit, risk, and compliance management.
Qualio
A cloud-based electronic quality management system (eQMS) for life sciences companies.
Dot Compliance
An AI-powered eQMS solution built natively on the Salesforce platform, offering ready-to-deploy quality and compliance processes.
Rimsys
A Regulatory Information Management (RIM) platform built by and for medical technology regulatory professionals.
Schlafender Hase TVT
A software tool for automated proofreading of text and graphics in regulated documents, primarily for labeling and packaging.
Rimsys
A Regulatory Information Management (RIM) platform built exclusively for medical devices.
Specright
A cloud-based platform for managing all specification data, from raw materials to finished goods.
Qualio
A cloud-based electronic quality management system (eQMS) for life sciences companies.
Generis CARA Life Sciences Platform
A platform for managing structured and unstructured data and content for regulated industries, including RIM, QMS, and clinical.
ManageArtworks
A cloud-based packaging and artwork lifecycle management system for regulated industries.
LogicGate Risk Cloud
A no-code platform for governance, risk, and compliance (GRC) process automation.
Workiva
A cloud platform for reporting, ESG, audit, and risk.
Hyperproof
A compliance operations platform for managing security and privacy compliance.
VComply
A cloud-based platform for governance, risk, and compliance (GRC) management.
Diligent
A GRC platform for boards and leadership.
Generis CARA
A unified platform for managing content and data in regulated industries, including RIM.
AmpleLogic
A low-code/no-code platform for building quality and compliance applications for the pharmaceutical industry.
LogicGate Risk Cloud
A no-code platform for governance, risk, and compliance (GRC).
EXTEDOpulse
A comprehensive RIM software solution for the pharmaceutical and life sciences industry.
ComplianceQuest
An EQMS built on the Salesforce platform, with solutions for regulatory compliance.
Parexel Lorenz docuBridge
An advanced electronic submission management system for compiling, publishing, and reviewing regulatory dossiers like eCTD.
Montrium RIM
A cloud-based RIM platform designed to help emerging life sciences companies manage their regulatory information and submissions.
Freyr iReady
A RIM solution that enables effective management of product registrations, marketing authorization lifecycles, and regulatory documents.
Ennov RIM
A process-driven RIM solution for managing product portfolios worldwide.
Montrium Regulatory Navigator
A solution for managing regulatory documents and submissions within a regulated content management system.
DocuSign for Life Sciences
A solution for compliant electronic signatures and agreements in the life sciences.
ComplianceQuest
A modern EQMS, EHS, and QMS platform built on the Salesforce platform.
TransPerfect Trial Interactive
An e-clinical technology solution that includes eTMF and other study management tools.
TEKLYNX CENTRAL
A browser-based, centralized label management system for creating, approving, and printing labels.
BarTender
Software to create and automate the printing of labels, barcodes, and RFID tags.
Veeva Vault PromoMats
A cloud-based application for managing the entire lifecycle of promotional content in the life sciences industry.
Ideagen
Provides a suite of software solutions for GRC, including quality, safety, audit, and risk management.
Veeva Vault
A cloud platform for the life sciences industry, including regulatory, quality, and clinical solutions.
Resolver
A GRC platform for managing risk, compliance, and incidents.
OneTrust
A platform for privacy, security, and governance.
NAVEX
A platform for risk, compliance, and ethics management.
ZenGRC by RiskOptics
A GRC platform for managing risk and compliance.
ServiceNow GRC
A GRC solution built on the ServiceNow platform.
EXTEDO RIM ONE
A modular RIM platform consisting of five hubs that can be used individually or together to manage the regulatory lifecycle.
SAI360
A cloud-based platform for managing risk, compliance, and ethics.
ETQ Reliance
A quality management, EHS, and compliance platform.
Qualys
A cloud platform for IT, security, and compliance.
Ennov RIM
A comprehensive RIM software solution for managing global regulatory information.
SAP S/4HANA for product compliance
An enterprise solution for managing product compliance, including regulatory requirements.
ETQ Reliance
A flexible and scalable quality management system (QMS) with regulatory compliance features.
MetricStream
A comprehensive GRC platform with solutions for regulatory compliance.
Veeva Vault RIM Suite
A cloud-based platform for managing regulatory submissions, product registrations, and health authority interactions.
MasterControl Regulatory Excellence
Connects the entire product development lifecycle, ensuring regulatory compliance from conception to commercialization.
Veeva Vault RIM
Cloud-based Regulatory Information Management (RIM) suite for the life sciences industry.
MasterControl Regulatory Excellence
An integrated solution for managing submissions, registrations, and regulatory data.
Veeva Vault Submissions
Part of the Veeva Vault RIM Suite, it provides a single source for all submission documents and data.
MasterControl eCTD Publishing
An eCTD publishing solution that integrates with a comprehensive quality management system.
Loftware Spectrum
A comprehensive solution for designing, managing, and printing labels and artwork across the supply chain.
MetricStream
An integrated Governance, Risk, and Compliance (GRC) platform that helps organizations manage risk and ensure regulatory compliance.
MasterControl
Provides quality management software (QMS) to help regulated companies streamline compliance and get products to market faster.
MetricStream
An enterprise platform for Governance, Risk, and Compliance (GRC) and Integrated Risk Management (IRM).
MasterControl
A quality management system (QMS) for regulated industries.
Archer
An integrated risk management (IRM) platform.
Veeva Vault RIM
Cloud-based regulatory information management (RIM) software for the life sciences industry.
MasterControl Regulatory Excellence
A solution that automates and streamlines regulatory submission processes.
ArisGlobal LifeSphere RIM
A SaaS-based RIMS solution that uses a process-based approach for tracking and managing all regulatory affairs submissions.
Calyx RIM
A proven, scalable RIM system for managing and tracking all regulatory information, from clinical applications to post-market activities.
Esko WebCenter
A web-based platform for managing the packaging pre-production process, including specifications, approval, and project lifecycle.
SAP GRC
A suite of solutions for governance, risk, and compliance from SAP.
ArisGlobal LifeSphere RIM
A unified, cloud-based platform for managing the entire regulatory lifecycle.
Oracle Argus Safety
A comprehensive platform for managing drug safety and pharmacovigilance, with regulatory reporting capabilities.
Trace One
A platform for product lifecycle management (PLM) and compliance for the retail and CPG industries.
IQVIA RIM Smart
A fully integrated, technology-led platform for managing the complete regulatory lifecycle, from submission to post-market surveillance.
Ennov RIM
A modular RIM solution that supports the end-to-end regulatory lifecycle, from submission tracking to registration updates.
OpenText Documentum for Life Sciences
A comprehensive, purpose-built solution for managing regulated content.
ArisGlobal LifeSphere Labeling
A solution for managing the entire labeling lifecycle, from core data sheet to final label.
BLUE Software
A solution for managing the development and approval of labeling and packaging artwork.
IQVIA RIM Smart
An end-to-end regulatory information management platform for the life sciences industry.
OpenText Documentum for Life Sciences
Content management solutions to control all content, including documents, images, and email, related to clinical, quality, and regulatory.
TrackWise Digital
A cloud-based Quality Management System (QMS) with regulatory management capabilities.
TrackWise Digital (Sparta Systems)
A cloud-based Quality Management System (QMS) built on the Salesforce platform for managing quality and compliance.
Sparta Systems - TrackWise Digital
An enterprise quality management software (EQMS) for regulated industries.
Sparta Systems TrackWise Digital
A cloud-based enterprise quality management software (QMS) with regulatory management capabilities.
Sparta Systems TrackWise Digital
A leading QMS platform that helps life sciences companies manage quality, compliance, and regulatory processes.
Instem Samarind RMS
A RIM system where data is entered once and reused across submissions, renewals, variations, and other regulatory activities.
Amplexor Life Sciences Suite
A suite of tools to manage regulated content and processes, helping clients achieve and maintain global regulatory compliance.
Phlexglobal PhlexRIM
A complete, end-to-end RIM platform that automates the management of product and registration information.
DDi ViSU
A cloud-based RIM platform for medical device companies to manage regulatory data, dossiers, submissions, and compliance.
Veratrak
A platform for secure document collaboration and data exchange between pharmaceutical companies and their supply chain partners.
IQVIA RIM Smart
An end-to-end regulatory information management system for pharma and MedTech.
LORENZ docuBridge
An advanced electronic submission management and publishing system.
ArisGlobal LifeSphere RIM
A unified, cloud-based platform for end-to-end regulatory information management.
Freyr rDMS
An intelligent platform for regulatory document management and compliance.
EXTEDOpulse
A comprehensive RIM software solution consisting of five interconnected hubs.
AmpleLogic RIMS
A low-code RIM system to streamline product application and registration.
DDi ViSU
A cloud-based RIM platform designed specifically for the medical device industry.
Instem SUBMIT
A suite of tools focused on creating and managing SEND datasets for regulatory submissions.
Phlexglobal PhlexRIM
A modular RIM software for planning, tracking, and managing regulatory activities.
Samarind RMS
A modular software solution for managing regulatory information and processes.
Calymantra eCTD Express
A desktop eCTD publishing tool designed for affordability and ease of use.
Freyr SUBMIT PRO
A cloud-based eCTD submission software for the life sciences industry.
GlobalSubmit PUBLISH
eCTD publishing software for creating and submitting compliant regulatory submissions.
EXTEDOpulse
A comprehensive RIM software solution for the life sciences industry.
LORENZ docuBridge
An advanced electronic submission management system for compiling, publishing, and reviewing regulatory submissions.
PhlexSubmission
A robust and configurable publishing engine for electronic submissions.
pharmaREADY
A fully integrated, regulatory compliant, web-based platform for global regulatory submissions.
Ennov Dossier
A regulatory submission publishing software that is integrated with a comprehensive EDMS.
Samarind eCTD
An eCTD submission management tool for the pharmaceutical industry.
Glemser eCTD
Provides solutions for regulatory compliance, including eCTD submissions.
e-Submissions Manager
A software for managing electronic submissions.
Cuneso eCTD
Offers services and solutions for eCTD submissions.
DocuSharen D2
A platform for secure document sharing and collaboration, with applications in regulatory submissions.
Amplexor myProcess
A suite of solutions for content management and regulatory compliance.
NextGen eCTD
A comprehensive software solution for creating, managing, and publishing eCTD submissions.
Ziva DRA
An eCTD software tool for preparing, validating, and submitting electronic regulatory content.
Artixio eCTD Publishing
Provides comprehensive regulatory operation services for eCTD and NeeS submissions.
Mono eCTD Office
An eCTD software tool for electronic submissions.
Educe Solution
A provider of eCTD software solutions.
RIM INSIGHTS
An eCTD software tool.
Please+Publish
An eCTD publishing software that automates formatting and enhances quality control.
Kallik Veraciti
A cloud-native platform providing a single source of truth for product packaging and labeling assets.
Freyr LABEL 360
A tool to manage label changes globally in a streamlined and timely manner.
Perigord GLAMS
A web-based artwork management solution for the life sciences industry.
Innovatum ROBAR
An enterprise label management system for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
Loftware PRISYM 360
A validation-ready, cloud-based label printing platform for the clinical trials industry.
Redica Systems
Unifies global regulatory intelligence, inspection data, and supplier insights to predict and prevent compliance risks.
IQVIA RIM Smart
An end-to-end Regulatory Information Management (RIM) system for life sciences to manage the full product lifecycle.
RegDesk
An AI-powered RIMS platform for medical device, pharma, and IVD firms that streamlines global compliance and automates submissions.
Thomson Reuters Regulatory Intelligence
A comprehensive solution for managing regulatory risk by tracking global developments and mapping obligations to internal controls.
Compliance.ai
An AI-powered platform that monitors, analyzes, and maps regulatory changes to internal policies and controls.
AmpleLogic
Provides a suite of GMP-compliant software solutions for the pharmaceutical industry, including QMS, DMS, and LMS.
Freyr rDMS
A regulatory document management system for the life sciences industry.
RegDesk
An AI-powered platform for managing regulatory submissions and intelligence.
Samarind RMS
A comprehensive software solution for managing regulatory information and processes.
CUBE
An AI-powered platform for automated regulatory intelligence and change management.
Coptis
A software solution for managing cosmetic formulation, testing, and regulatory compliance.