Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

Our Customers

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows

Our Customers

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows

Our Customers

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows

Our Customers

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

"Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions.

We can’t live without the platform.”

"Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions.

We can’t live without the platform.”

JOHN LANSDOWN

GM - Quality, Regulatory and Compliance

"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

MARTA STEPIEN

VP of Clinical, Regulatory and Quality Affairs

VP of Clinical, Regulatory and Quality Affairs

VP of Clinical, Regulatory and Quality Affairs

VP of Clinical, Regulatory and Quality Affairs

Want to learn more about the Essenvia RIM Platform?

Want to learn more about the
Essenvia RIM Platform?

Contact us for a Free Demo!

Contact us for a Free Demo!

Contact us for a Free Demo!