Reduce your time to submission and get 100% acceptance rate

Essenvia´s unique and patented technolgy supercharges global regulatory submissions, including the new FDA eSTAR submission process and the transition to MDR.

AI-powered SSupercharge the new FDA eSTAR submission process and master the transition to MDR.

Supercharge the new FDA eSTAR submission process and master the transition to MDR.

AI-powered SSupercharge the new FDA eSTAR submission process and master the transition to MDR.

See it in Action

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

How can the Essenvia RIM Platform help you manage your regulatory submissions?

Battle-tested Templates

Extensive library of templates compliant
with all regulations and countries.

Reusable Content Automation

Automation of reusable content across submissions and integration with eQMS/PLM (also on eSTAR submissions).

FDA eSTAR Collaborative Authoring

Essenvia is the only platform on the planet that allows collaborative work on eSTAR submissions (thanks to our patented technology).

100% Acceptance Rate

Instantly generate final submission files with 1-Click.
100% submission acceptance rate.

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

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Want to learn more about the Essenvia RIM Platform?

Want to learn more about the
Essenvia RIM Platform?

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