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 Essenvia RIM Platform
explained in in two minutes

The Essenvia RIM Platform
explained in in two minutes

The Essenvia RIM Platform
explained in in two minutes

The Essenvia RIM Platform
explained in in two minutes

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

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, 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.

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!

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