Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
"The eSTAR and RIM systems ensure 100% submissions accuracy and project tracking, while the submission edit features expedite processes and facilitate collaboration. They provided exceptional custemer service, and the Essenvia technology exceeded our expectations, providing to be an invaluable asset to our company."
Jaya Tiwari
VP of Clinical and Regulatory Affairs
“We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to this Platform our team was able to work together in one single place at any time to author, edit, and review the submission. As a regulatory leader, i also love seeing the total progress of the submission and individual sections as it’s being prepared and completed.
Once the submission was ready in the Essenvia Platform, we were able to instantly publish into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)”
Marta Stepien
VP of Clinical, Regulatory and Quality Affairs
It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.
Here’s just a taste of what Essenvia can do for your company:
Provides an easy digital walkthrough of every step
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
Gives a one-click preview of the native eSTAR file
