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.
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.
We work with regulatory businesses worldwide
Trusted by Regulatory Affairs Teams Globally
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people.
Director Regulatory Affairs
Top 30 Medtech
The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use.
Sr. Regulatory Affairs Specialist
Top 3 Medtech
We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that.
Sr. Director, Global Regulatory Submissions
Top 5 Medtech
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
The ability to have users manage specific eSTAR sections is really cool.
Manager Regulatory Affairs
Top 30 Medtech
Super user friendly, and I really like the modular approach.
Manager Regulatory Affairs
Top 40 Medtech
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people.
Director Regulatory Affairs
Top 30 Medtech
The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use.
Sr. Regulatory Affairs Specialist
Top 3 Medtech
We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that.
Sr. Director, Global Regulatory Submissions
Top 5 Medtech
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
The ability to have users manage specific eSTAR sections is really cool.
Manager Regulatory Affairs
Top 30 Medtech
Super user friendly, and I really like the modular approach.
Manager Regulatory Affairs
Top 40 Medtech
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people.
Director Regulatory Affairs
Top 30 Medtech
The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use.
Sr. Regulatory Affairs Specialist
Top 3 Medtech
We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that.
Sr. Director, Global Regulatory Submissions
Top 5 Medtech
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
The ability to have users manage specific eSTAR sections is really cool.
Manager Regulatory Affairs
Top 30 Medtech
Super user friendly, and I really like the modular approach.
Manager Regulatory Affairs
Top 40 Medtech
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people.
Director Regulatory Affairs
Top 30 Medtech
The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use.
Sr. Regulatory Affairs Specialist
Top 3 Medtech
We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that.
Sr. Director, Global Regulatory Submissions
Top 5 Medtech
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
The ability to have users manage specific eSTAR sections is really cool.
Manager Regulatory Affairs
Top 30 Medtech
Super user friendly, and I really like the modular approach.
Manager Regulatory Affairs
Top 40 Medtech
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
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 did not fit into our workflows”
Sejal Chitre
Director Global Regulatory Affairs
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without using the platform now.”
John Landsdown
Director of Quality, Regulatory Affairs & Compliance
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
VP of Clinical, Regulatory and Quality Affairs
Learn More About the Essenvia RIM Platform
Contact us for a Demo
Learn More About the Essenvia RIM Platform
Contact us for a Demo
Learn More About the Essenvia RIM Platform
Contact us for a Demo