# Essenvia Reviews **Vendor:** Essenvia **Category:** [Regulatory Information Management (RIM) Systems](https://www.g2.com/categories/regulatory-information-management-rim-systems) **Average Rating:** 4.7/5.0 **Total Reviews:** 3 ## About Essenvia Essenvia is an online platform to streamline regulatory pathway for medical device companies. FDA research data indicates that regulatory submissions have grown in complexity and size with an average of 1185 pages per submission, with a consistent 30% rejected at initial review and 64% sent back for additional information. Essenvia’s regulatory software streamlines the regulatory submission process by improving collaboration and automating some of the most time-consuming and error-prone tasks. Submissions processed on Essenvia reduce time and effort by 40% and eliminate 52% of errors. We are determined to reduce avoidable errors in regulatory submission and help medical device companies accelerate time to market. ## Essenvia Reviews ### 1. Easy-to-Use Platform for Fast, Global Regulatory Submission Assembly **Rating:** 5.0/5.0 stars **Reviewed by:** Frank P. | Board of DIrectors. RAPS - Regulatory Affairs Professional Society, Mid-Market (51-1000 emp.) **Reviewed Date:** April 02, 2026 **What do you like best about Essenvia?** Essenvia is an easy-to-use platform for assembling regulatory submissions. The outputs cover the US/FDA, the EU and other countries. It can be configured and it coves other functions including change management, integrating activities into a single source and allowing for a rapid collection and assembly of documents from across the entire company. Easy to install and able to be used by a variety of departments. **What do you dislike about Essenvia?** Solid customer support in case there are questions about use and applications. **What problems is Essenvia solving and how is that benefiting you?** Essenvia logically collects and assembles documents to get healthcare products approved in different countries ### 2. Revolutionizes Regulatory Submissions with AI Power **Rating:** 4.0/5.0 stars **Reviewed by:** John L. **Reviewed Date:** December 03, 2025 **What do you like best about Essenvia?** I love Essenvia's new AI features, particularly for their efficient ability to construct over 50% of a regulatory submission for multiple countries based on an existing FDA submission. This capability not only streamlines the entire submission process but also ensures accuracy by identifying gaps needed to complete a submission comprehensively. Essenvia's AI impresses me with how it utilizes previous regulatory submissions and interactions with the FDA to draft new submissions that meet previously identified requirements or discrepancies. The AI can effectively discern essential components of a submission based solely on a device's description or overview, saving me significant time and effort. Furthermore, I am impressed by the software's ability to automatically create tables of contents and tables of tables & figures, and even generate a complete eCopy submission immediately after last-minute edits. I also appreciate how user-friendly the setup was, with Essenvia's staff always available to address questions. This responsiveness aids in a smoother transition from manual submission creation, underscoring the efficiency and support quality that Essenvia offers. **What do you dislike about Essenvia?** One of the eSTARs generated by Essenvia was corrupted, which caused issues during the submission process. Initially, it was accepted by the FDA, but it was not accepted when submitting the response to the AINN. This required me to rebuild the eSTAR manually. Additionally, I feel that the integrated, user-friendly help or tool tips could be improved to assist further with the software usage. **What problems is Essenvia solving and how is that benefiting you?** I use Essenvia to automate regulatory submissions, saving time on manual tasks by generating documents instantly and identifying submission gaps with AI. ### 3. Effortlessly Manages Regulatory Updates **Rating:** 5.0/5.0 stars **Reviewed by:** Sophia M. | Software Quality Engineer II **Reviewed Date:** November 17, 2025 **What do you like best about Essenvia?** I appreciate that Essenvia is consistently rolling out updates, indicating that the product is always improving. This progression and attention to development is exactly the type of software my company values investing in. Although I'm not a direct user, I admire the culture and flexibility of their staff. Their team is highly receptive, especially when it comes to leveraging internal testing, which helps us avoid duplicate testing efforts. The initial setup of Essenvia was easy, which made the transition smooth. Overall, I rate it highly and would undoubtedly recommend Essenvia to others. **What do you dislike about Essenvia?** I feel that the AI Search feature in Essenvia could be improved as it currently struggles to filter the most relevant searches first, which impacts product updates. **What problems is Essenvia solving and how is that benefiting you?** I use Essenvia for regulatory updates and to manage time efficiently with pending updates and deadlines, leveraging its improved features and flexible support to avoid duplicate testing. - [View Essenvia pricing details and edition comparison](https://www.g2.com/products/essenvia/reviews?section=pricing&secure%5Bexpires_at%5D=2026-06-11+22%3A13%3A38+-0500&secure%5Bsession_id%5D=ebd0ce97-9189-49d0-b9ff-c41aa8cda3ac&secure%5Btoken%5D=6c4150349ada6464750352a4b85c73857cab10c165424d79155e301eaacbf48e&format=llm_user) ## Essenvia Features **Document Management** - Dossier Management - Tech Files - Submission Planning - Archiving **Product Management** - Audit Trails - Label Management - Live Dashboards - Collaborative Authoring - Product Information **Regulatory Affairs** - Automated Notifications - Post-Market Surveillance - Communication Tools - Regulatory Intelligence ## Top Essenvia Alternatives - [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) - 4.3/5.0 (521 reviews) - [Clinical Research Suite](https://www.g2.com/products/clinical-research-suite/reviews) - 3.8/5.0 (204 reviews) - [Rimsys](https://www.g2.com/products/rimsys/reviews) - 4.7/5.0 (15 reviews)