4 min read
April 24, 2025
Entvin (YC S22) Launches Ask AI: A Game-Changer for Regulatory Professionals
Entvin (YC S22) is excited to announce a new feature update designed to address a major challenge faced by regulatory professionals. After listening to customer feedback, we have launched the Ask AI feature, specifically tailored for FDA review documents, EPARs, and product labels to find you those critical insights that will shape your strategy.
What is Ask AI?
Ask AI is an intelligent search tool that allows users to quickly extract critical insights from complex regulatory documents. Whether you’re dealing with FDA review files or EMA’s EPARs, Ask AI helps you find the key information that matters for your strategic decisions.
How Does Ask AI Help?
Regulatory professionals often find themselves digging into the FDA Review documents or EPAR for EMA.
This helps them figure out what conversations went behind the final conclusions in the label.
Example:
How did the final approved indication differ from what was initially proposed?
What key changes to the SmPC were required during assessment?
Were there differences in opinion about dosing, patient population, or contraindications?
Were there any "major objections" or "critical issues" specifically highlighted in the report?
What statistical methods or endpoints did FDA challenge or request modifications for?
These documents are generally very difficult to read, OCRed at the same time most often then not the answers lies in redacted information or actually reading graphs or tables.
We have trained our AI agents to connect the dots from various parts of review documents like a regulatory professional would do to get you those insights at your fingertips.
Get Started
This update is now live for all Entvin users. Try Ask AI today and experience a smarter, faster way to navigate regulatory documents.
Entvin is committed to empowering regulatory professionals with tools that make a real difference. Stay tuned for more updates!
