Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Understand how Essenvia makes
eSTAR faster and collaborative

Understand how Essenvia makes eSTAR faster and collaborative

Understand how Essenvia makes
eSTAR faster and collaborative

Understand how Essenvia makes
eSTAR faster and collaborative

Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

MARTA STEPIEN

MARTA STEPIEN

MARTA STEPIEN

VP of Clinical, Regulatory and Quality Affairs

VP of Clinical, Regulatory and Quality Affairs