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

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

Discover More

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

Discover More

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

Discover More

About Us

Our mission is to guide MedTech companies toward regulatory excellence for the purpose of accelerating the delivery of innovative medical solutions to patients.

Our mission is to guide MedTech companies toward regulatory excellence for the purpose of accelerating the delivery of innovative medical solutions to patients.

Our mission is to guide MedTech companies toward regulatory excellence for the purpose of accelerating the delivery of innovative medical solutions to patients.

Founded in 2018, Essenvia is a US-headquartered tech company focused on providing innovative MedTech regulatory solutions to expedite the time-to-market of innovative healthcare solutions.


Our flagship product, the Essenvia Regulatory (RIM) Platform, is the most reliable way to manage regulatory requirements that fit your regulatory workflow to efficiently produce and sustain high-quality medical products while aligning with company KPIs.

Founded in 2018, Essenvia is a US-headquartered tech company focused on providing innovative MedTech regulatory solutions to expedite the time-to-market of innovative healthcare solutions.


Our flagship product, the Essenvia Regulatory (RIM) Platform, is the most reliable way to manage regulatory requirements that fit your regulatory workflow to efficiently produce and sustain high-quality medical products while aligning with company KPIs.

350+

350+

Submissions prepared with the
Essenvia RIM Platform

100+

100+

New medical devices
brought to market

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

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.

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, 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. 100% submission acceptance rate guarantee.