Top 10 Best Regulatory Submissions Software of 2026

Veeva Vault Submissions is a cloud-native platform designed for life sciences companies to manage the entire regulatory submissions lifecycle, from dossier assembly to health authority publishing. It supports global standards like eCTD, IDMP, and NeeS, with automated validation, collaboration tools, and seamless integration across Veeva's Vault suite for RIM, Quality, and Clinical. The solution ensures compliance, accelerates review cycles, and provides real-time visibility into submission status worldwide.

GlobalSubmit by Clarivate is a cloud-based regulatory submissions platform tailored for life sciences companies, enabling end-to-end management of electronic Common Technical Document (eCTD) submissions to agencies like the FDA and EMA. It offers modules for validation, publishing, viewing, and archiving, ensuring compliance with global standards such as eCTD v4.0 and IDMP. The platform integrates with RIM systems like Veeva Vault, streamlining workflows from dossier compilation to agency delivery.

docuBridge by Lorenz is a specialized regulatory submissions software suite for life sciences companies, enabling the creation, validation, publishing, and review of electronic Common Technical Document (eCTD) submissions. It supports global standards including ICH, FDA, EMA, and emerging formats like eCTD v4.0, with tools for lifecycle management, stakeholder review, and compliance checks. The platform integrates with enterprise RIM systems to streamline the end-to-end submission process from authoring to agency delivery.

RIMSYS is a cloud-based Regulatory Information Management System (RIMS) designed primarily for medical device manufacturers to manage global regulatory submissions and compliance. It offers tools for electronic submission preparation (eSubmissions), dossier lifecycle management, submission tracking, and regulatory intelligence across 150+ countries. The platform automates workflows, ensures data reuse, and facilitates collaboration between regulatory teams and partners.

Freyr SUBMITS is a cloud-based regulatory submissions platform from Freyr Solutions that manages the end-to-end lifecycle of regulatory dossiers for life sciences companies. It supports eCTD, NeeS, IDMP, and regional formats, enabling planning, authoring, validation, publishing, and tracking of submissions to agencies like FDA, EMA, and Health Canada. The software integrates with RIM systems and provides real-time compliance checks and analytics for efficient global regulatory operations.

MasterControl is a comprehensive quality management system (QMS) platform with specialized modules for regulatory submissions, enabling life sciences and manufacturing organizations to create, manage, and publish electronic submissions like eCTD dossiers to agencies such as FDA and EMA. It integrates submission workflows with document control, CAPA, training, and audit management for end-to-end compliance. The software supports validation, collaborative reviews, and automated publishing to ensure regulatory accuracy and efficiency.

Montrium eCTDmanager is a cloud-based SaaS platform specialized in the authoring, validation, review, and publishing of electronic Common Technical Documents (eCTDs) for regulatory submissions to agencies like the FDA, EMA, Health Canada, and others. It provides end-to-end lifecycle management for regulatory dossiers, including sequence assembly, compliance checking against ICH standards, and secure collaboration tools for global teams. The software integrates with enterprise document management systems and supports non-eCTD formats like NeeS, ensuring flexibility for pharmaceutical, biotech, and medtech organizations.

Certara Regulus is a cloud-based regulatory information management (RIM) and submissions platform that enables pharmaceutical and biotech companies to compile, validate, review, and publish regulatory dossiers in formats like eCTD and IDMP. It provides end-to-end lifecycle management for submissions, including content authoring, quality control, and agency gateway integration. Integrated with Certara's biosimulation tools, it supports data-driven decision-making while ensuring global regulatory compliance.

eCTDmax by DHC Swiss is a specialized software platform for managing electronic Common Technical Document (eCTD) submissions in the pharmaceutical and life sciences industries. It facilitates the authoring, validation, publishing, and lifecycle management of regulatory dossiers compliant with standards from FDA, EMA, PMDA, and other agencies. The tool integrates with document management systems and offers automation to streamline submission processes while ensuring data integrity and audit trails.

RegDesk is a regulatory intelligence and compliance platform tailored for life sciences companies, offering a vast database of regulations across 150+ countries to support submission planning and management. It leverages AI for real-time tracking of regulatory changes, dossier building, and collaboration tools to streamline global market access. While strong in intelligence gathering, it focuses more on pre-submission preparation than direct eCTD filing compared to top-tier tools.