Top 10 Best Regulatory Submission Tracking Software of 2026

Veeva Vault Submissions is a cloud-native platform that streamlines the entire regulatory submission lifecycle for life sciences organizations, from planning and authoring to review, validation, and publishing in formats like eCTD, IDMP, and NeES. It ensures global regulatory compliance with built-in support for FDA, EMA, and other agencies, while integrating seamlessly with Veeva's broader Vault RIM suite for unified content management. The solution leverages AI-driven automation for milestone tracking, quality checks, and real-time collaboration, reducing submission errors and timelines significantly.

MasterControl is a comprehensive enterprise quality management system (eQMS) designed for regulated industries, with strong capabilities in regulatory submission tracking for life sciences, manufacturing, and medical devices. It enables users to manage submission dossiers, track milestones and timelines, automate approval workflows, and maintain compliance with standards like FDA 21 CFR Part 11, EMA, and ISO. The platform integrates document control, electronic signatures, and reporting to streamline regulatory affairs processes from planning to post-submission monitoring.

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) tailored for medical device companies, enabling efficient management of regulatory submissions such as 510(k), PMA, and Technical Files. It centralizes document control, design history files (DHF), risk management, and CAPA processes to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR requirements. The platform tracks submission status, automates workflows, and provides audit-ready trails to accelerate regulatory approvals.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed for life sciences companies, focusing on document control, change management, CAPA, training, and supplier management to ensure regulatory compliance. For regulatory submission tracking, it offers strong document lifecycle management with version control, automated workflows, electronic signatures, and full audit trails compliant with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. However, it lacks specialized tools for eCTD assembly, submission publishing, or real-time tracking of agency acknowledgments and review statuses, requiring integrations for full submission workflows. It's best suited as a foundational QMS that supports submission preparation rather than end-to-end tracking.

TrackWise Digital by Honeywell is a cloud-based enterprise quality management system (QMS) tailored for life sciences industries, featuring modules for regulatory submission tracking, including planning, milestone management, and eCTD compilation support. It enables centralized tracking of submissions to agencies like FDA and EMA, with automated workflows, collaboration tools, and real-time reporting for compliance. The platform integrates AI-driven analytics to predict delays and risks, ensuring audit-ready documentation across the regulatory lifecycle.

EXTEDO eCTDmanager is a specialized platform for regulatory professionals in the life sciences industry, designed to streamline the authoring, validation, assembly, and submission of electronic Common Technical Documents (eCTD). It supports ICH standards and regional variations (e.g., FDA, EMA), including lifecycle management, baseline building, and viewer functionalities. The software integrates with document management systems to ensure compliance and efficient tracking of submission processes across global regulatory agencies.

Dot Compliance is a cloud-based Quality Management System (QMS) tailored for regulated industries like life sciences, focusing on streamlining compliance processes such as document control, training, CAPA, audits, and nonconformance management. It supports regulatory submission tracking through workflow automation, version control, and electronic signatures compliant with 21 CFR Part 11 and other standards. While effective for general compliance, its submission tracking is integrated within broader QMS functionalities rather than being a standalone specialized module.

SimplerQMS is a cloud-based Quality Management System (QMS) designed for life sciences industries, focusing on document control, process automation, and regulatory compliance. It supports managing regulatory documentation through version control, electronic signatures, workflows, and audit trails compliant with 21 CFR Part 11 and ISO 13485. While effective for handling submission-related documents, it lacks specialized tools for eCTD publishing, submission planning, or agency milestone tracking, positioning it as a general QMS rather than a dedicated regulatory submission tracker.

Ennov Regulatory is a comprehensive regulatory information management (RIM) platform tailored for life sciences organizations to manage the entire regulatory submission lifecycle. It enables planning, tracking, and execution of submissions across global authorities like FDA and EMA, with support for eCTD publishing and milestone management. The software integrates with other Ennov modules for a unified workflow, ensuring compliance and visibility into regulatory activities.

LifeSphere RIM by ArisGlobal is a cloud-based Regulatory Information Management (RIM) platform designed to streamline regulatory submission tracking, planning, and management for life sciences companies. It provides end-to-end visibility into submission timelines, dossiers, variations, and renewals across global health authorities, with automated workflows and compliance tools. The software integrates regulatory intelligence and supports multi-region requirements, reducing manual efforts and enhancing submission success rates.