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Customers

We work with MedTech companies worldwide

Case Study

How AI-Powered Submissions Automation Accelerated Time to Market for a Top MedTech

Regulatory complexity shouldn’t slow growth, but for many global MedTech companies, it does.

AI submissions

Case Study

How Terumo Reg Affairs leverages Essenvia

Increase efficiency, simplify regulatory workflows, improve data accessibility, and support growth and complexity in regulatory compliance by indexing organized regulatory information.

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We work with regulatory businesses worldwide

Trusted by Regulatory Affairs Teams Globally

I’ve seen a lot of so-called AI softwares but very few are actually AI, and this [Essenvia] is the real deal.

Regulatory VP · Top 15 Medtech

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Essenvia RIM is easy to use and fast to setup. We save at least 20% of our time with using Essenvia's capabilities. Our experience with other RIMS tools made day-to-day operations more complex and did not fit into our workflows

Sejal Chitre

Sejal Chitre

Director Global Regulatory Affairs

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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 using the platform now.

John Landsdown

John Landsdown

Director of Quality, Regulatory Affairs & Compliance

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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.

Marta Stepien

Marta Stepien

VP of Clinical, Regulatory and Quality Affairs

I’ve seen a lot of so-called AI softwares but very few are actually AI, and this [Essenvia] is the real deal.

Regulatory VP · Top 15 Medtech

Quote Icon

Essenvia RIM is easy to use and fast to setup. We save at least 20% of our time with using Essenvia's capabilities. Our experience with other RIMS tools made day-to-day operations more complex and did not fit into our workflows

Sejal Chitre

Sejal Chitre

Director Global Regulatory Affairs

Quote Icon

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 using the platform now.

John Landsdown

John Landsdown

Director of Quality, Regulatory Affairs & Compliance

Quote Icon

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.

Marta Stepien

Marta Stepien

VP of Clinical, Regulatory and Quality Affairs

I’ve seen a lot of so-called AI softwares but very few are actually AI, and this [Essenvia] is the real deal.

Regulatory VP · Top 15 Medtech

Quote Icon

Essenvia RIM is easy to use and fast to setup. We save at least 20% of our time with using Essenvia's capabilities. Our experience with other RIMS tools made day-to-day operations more complex and did not fit into our workflows

Sejal Chitre

Sejal Chitre

Director Global Regulatory Affairs

Quote Icon

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 using the platform now.

John Landsdown

John Landsdown

Director of Quality, Regulatory Affairs & Compliance

Quote Icon

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.

Marta Stepien

Marta Stepien

VP of Clinical, Regulatory and Quality Affairs

See what your portfolio looks like when everything is sellable — and audit-ready.

A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.

Book a demo

Read the customer stories

See what your portfolio looks like when everything is sellable — and audit-ready.

A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.

Book a demo

Read the customer stories

See what your portfolio looks like when everything is sellable — and audit-ready.

A 30-minute demo, on your products and your markets. No sandbox, no trial to configure — a working conversation with people who know regulatory.

Book a demo

Read the customer stories