Top 10 Best Regulatory Affairs Software of 2026

Veeva Vault RIM is a cloud-native Regulatory Information Management (RIM) platform tailored for life sciences companies, enabling end-to-end management of regulatory submissions, registrations, planning, and dossiers. It unifies regulatory data, content, and processes in a single source of truth, supporting global teams with real-time collaboration, automated workflows, and compliance to standards like eCTD, IDMP, and regional requirements. The solution integrates seamlessly with other Veeva Vault applications, accelerating time-to-market while minimizing compliance risks.

MasterControl is a robust enterprise Quality Management System (QMS) tailored for regulated industries like life sciences and manufacturing, offering comprehensive tools for document control, CAPA, audit management, training, and change control to ensure regulatory compliance. It streamlines regulatory affairs processes such as electronic submissions, risk management, and supplier quality oversight with pre-validated workflows. The cloud-based platform integrates seamlessly with ERP and other systems, supporting global operations and 21 CFR Part 11 compliance.

ArisGlobal LifeSphere Reg is a cloud-based Regulatory Information Management (RIM) platform tailored for life sciences organizations, enabling end-to-end management of regulatory activities from planning and submissions to tracking and compliance. It supports global regulatory requirements across multiple regions with automated workflows, content management, and submission publishing. The solution integrates AI and machine learning for enhanced intelligence, error reduction, and predictive planning, making it suitable for complex regulatory operations in pharma and biotech.

TrackWise Digital is a cloud-native Quality Management System (QMS) from Honeywell Sparta Systems, tailored for regulated industries like pharmaceuticals and biotech. It supports regulatory affairs through configurable workflows for change control, deviations, CAPA, audits, and submission tracking, ensuring compliance with FDA, EMA, and other global standards. Leveraging AI-driven insights and digital validation, it enables real-time collaboration and risk-based decision-making across the product lifecycle.

RIMSYS is a cloud-based Regulatory Information Management System (RIMS) tailored for the medical device industry, automating the regulatory lifecycle from initial planning and classification to submissions, approvals, and post-market surveillance. It centralizes documentation, tracks changes, and ensures compliance with global standards like FDA 510(k)/PMA, EU MDR/IVDR, and Health Canada requirements. The platform offers modular workflows, AI-driven insights, and collaboration tools to reduce submission times and minimize errors.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies to manage regulatory compliance and quality processes. It provides tools for design controls, risk management (including FMEA), CAPA, audits, document control, and training, all aligned with standards like FDA 21 CFR Part 820, ISO 13485, and EU MDR. The software features pre-configured templates and workflows tailored to medtech, automating compliance tasks and reducing manual errors.

Qualio is a cloud-based eQMS platform tailored for life sciences companies, focusing on quality and regulatory compliance through modules for document control, training, CAPA, audits, non-conformances, and supplier management. It supports standards like FDA 21 CFR Part 11, ISO 13485, and EU MDR, with pre-validation to accelerate GxP deployment. The software emphasizes connected quality processes and modern usability to help scaling biotech, pharma, and medtech firms maintain compliance efficiently.

ETQ Reliance is a cloud-based enterprise quality management system (QMS) tailored for regulatory compliance in highly regulated industries like life sciences, manufacturing, and medical devices. It provides configurable modules for document control, CAPA, audits, training management, complaints handling, and risk management to ensure adherence to standards such as FDA 21 CFR Part 11, ISO 13485, and GMP. The platform emphasizes no-code customization, enabling organizations to adapt workflows to specific regulatory requirements without heavy programming.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, designed to streamline compliance, quality processes, and regulatory affairs tasks for highly regulated industries like life sciences, manufacturing, and automotive. It provides end-to-end modules for CAPA, audits, complaints management, document control, training, and supplier quality, ensuring adherence to standards such as ISO 13485, FDA 21 CFR Part 11, and GxP. The platform leverages Salesforce's scalability for customizable workflows and real-time reporting, making it suitable for managing regulatory documentation and change control indirectly through quality governance.

ValGenesis VLMS is a cloud-based digital validation lifecycle management system tailored for the life sciences industry, enabling fully paperless validation processes. It supports risk-based validation strategies, real-time monitoring, and compliance with key regulations like FDA 21 CFR Part 11, EMA Annex 11, and GxP standards. The platform streamlines validation master planning, execution, and reporting, reducing manual efforts and audit risks.