Essenvia Reviews & Product Details

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. Review collected by and hosted on G2.com.

Solid customer support in case there are questions about use and applications. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.