Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions
Essenvia’s novel eSTAR submissions builder shortens time to market
and ensures business success. Start using our unique technology
to streamline your 510(k) eSTAR submissions and get a
100% submission acceptance rate.
Essenvia allows collaborative authoring and simultaneous users on FDA eSTAR submissions
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
Essenvia allows collaborative authoring and simultaneous users on FDA eSTAR submissions
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
Essenvia Customer for 2+ Years
“
By using Essenvia, we were able to complete and submit the FDA eSTAR application with ease. The Platform enabled us to have multiple colleagues working simultaneously on the same submission, facilitating the authoring, editing, and review process. We are thankful for the outstanding support provided by the Essenvia team”
By using Essenvia, we were able to complete and submit the FDA eSTAR application with ease. The Platform enabled us to have multiple colleagues working simultaneously on the same submission, facilitating the authoring, editing, and review process. We are thankful for the outstanding support provided by the Essenvia team”
Christine Jensen
VP of Regulatory Operations
Integrate with your PLM or eQMS to map and auto-update attachments
Integrate with your PLM or eQMS to map and auto-update attachments
Our eSTAR submission builder is patented and truly unique on the market
Our eSTAR submission builder is patented and truly unique on the market
Essenvia Customer for 3+ Years
“
We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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 they´re being prepared and completed.”
We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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 they´re being prepared and completed.”
Marta Stepien
VP of Clinical, Regulatory, and Quality Affairs
Easily adapt to eSTAR
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
Easily adapt to eSTAR
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
Easily adapt to eSTAR
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
Easily adapt to eSTAR
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
Learn more Essenvia’s resource-saving eSTAR platform
Want to learn more about the
Essenvia RIM Platform?
Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.
Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.
Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.