Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

The Regulatory Platform to

Achieve regulatory excellence

Essenvia is a MedTech RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value.

The Regulatory Platform to

Achieve regulatory excellence

Essenvia is a MedTech RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value.

The Regulatory Platform to

Achieve regulatory excellence

Essenvia is a MedTech RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value.

The Regulatory Platform to

Achieve regulatory excellence

Essenvia is a MedTech RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value.

If you are a…

VP/Head/Director of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

VP/Head/Director of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

VP/Head/Director of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

VP/Head/Director of Regulatory Affairs

…the Essenvia RIM Platform brings you:

1

Modern RIM technology that drives business value and brings cross-functional efficiency gains to all teams and departments (RA, QA, R&D, PMO).

2

Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals.

Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals.

3

Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global Registrations, Submissions, and Change Assessement.


Helicopter view of the complete regulatory cycle. Dashboards and progress metrics on global registrations, submissions and change manageme with alerts and notifications.

If you are a…

Specialist/Manager of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

Specialist/Manager of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

Specialist/Manager of Regulatory Affairs

…the Essenvia RIM Platform brings you:

If you are a…

Specialist/Manager of Regulatory Affairs

…the Essenvia RIM Platform brings you:

1

Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs and RFIs.

2

Powerful technology to support Registrations, Submissions, and Change Assessement, while increasing productivity and allowing regulatory specialists focus on high-value activities.

3

Peace of mind when dealing with ever-changing regulations for different regions and strict deadlines. with a 100% submission acceptance rate guarantee.


Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia

Essenvia's eSTAR platform changes everything

Allows collaborative authoring and simultaneous users

on FDA eSTAR submissions

Shortens time to market and ensures business success

Allows collaborative authoring and simultaneous users

on FDA eSTAR submissions

Shortens time to market and ensures business success

Allows collaborative authoring and simultaneous users

on FDA eSTAR submissions

Shortens time to market and ensures business success

Allows collaborative authoring and simultaneous users

on FDA eSTAR submissions

Shortens time to market and ensures business success

A Complete Regulatory Platform for MedTech Companies

A Complete Regulatory Platform for MedTech Companies

Module

Registrations
Management

Registrations
Management

Registrations
Management

Get a demo

Features include:

Manage product registration lifecycle by country

Central repository for all registration docs linked to product master data

Dashboard with ability to track global registration status

Alerts and notifications

Integration to ERP/PLM for data and document sync

Module

Submissions
Management

Submissions
Management

Submissions
Management

Get a demo

Features include:

Extensive templates library compliant with all regulations and countries

Reusable content automation across submissions

PLM/eQMS integration to automate submissions

FDA eSTAR collaborative authoring (unique and patented technology)

Instantly generate final submission files with 1-Click

Module

Change
Assessement

Change
Assessement

Change
Assessement

Get a demo

Features include:

Automate regulatory change assessment

Determine impact of change (significant or insignificant)

Automate creation of Letter to file / Memo to file

Project management across changes from initial assessment to closure

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

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!

Annual Report

2024 State of
US MedTech Regulation

Strategic insights and guidance for MedTech executives and regulatory professionals to navigate the US regulatory landscape and path to market for innovative medical devices in 2024 and beyond

Annual Report

2024 State of
US MedTech Regulation

Strategic insights and guidance for MedTech executives and regulatory professionals to navigate the US regulatory landscape and path to market for innovative medical devices in 2024 and beyond

Annual Report

2024 State of
US MedTech Regulation

Strategic insights and guidance for MedTech executives and regulatory professionals to navigate the US regulatory landscape and path to market for innovative medical devices in 2024 and beyond

Annual Report

2024 State of
US MedTech Regulation

Strategic insights and guidance for MedTech executives and regulatory professionals to navigate the US regulatory landscape and path to market for innovative medical devices in 2024 and beyond