Essenvia supercharges global regulatory submissions for MedTech regulatory affairs and QRM teams
We’re thrilled to announce that we’ve raised a $4M Pre Series A with Wavemaker360 and Benhamou Global Ventures, with participation from existing investors First Rays, Rebright partners, as well as Pasadena Angels – all to help supercharge MedTech regulatory submissions.
We’ve raised this capital for one simple reason: MedTech regulatory submissions are a very high-impact problem that still does not have an easy solution. 71% of MedTech regulatory submissions are rejected by regulatory bodies such as the FDA, costing manufacturers upwards of $1.8M of lost revenue for every 6-8 weeks in approval delay. Multiply that by the number of devices and markets each device is in, and the numbers get VERY BIG, VERY FAST.
Introduction
The lack of solutions to this problem is also staggering.
Traditional Regulatory Information Management (RIM) software takes 6+ months to implement, costs anywhere from $60k-$1M to license, and requires teams to rip and replace their existing processes and procedures. This is why most teams still rely on documents, spreadsheets, email, and instant messaging!
My co-founder Basant and I decided to flip this paradigm on its head and started Essenvia 4 years ago. We built Essenvia from the ground up to help regulatory teams streamline their submissions – and to do it on their own terms. Since then, Essenvia has become the fastest-growing regulatory submission platform – we’ve processed over 250 US and EU regulatory submissions for over 80 MedTech organizations with a 100% acceptance rate.
Instant Value on Day 1 (aka no implementations!)
And we’ve done it without upending the way regulatory teams work today or requiring long technical implementations and training sessions. You can create your first regulatory submission on day 1 with Essenvia. It’s super simple and intuitive. And, with our road-tested and customizable template library, in-line editing, error flagging, rich collaboration, granular permissions, and many other groundbreaking features, Essenvia offers the most powerful and easiest path to regulatory success for MedTech teams.
This funding round is an incredible validation of our focus and traction – and will only help fuel the rapid adoption we are seeing in the market. I couldn’t be more excited for what comes next for Essenvia and for this market!
Read the press release here: Essenvia Raises $4M Pre-A Round Led by Wavemaker and BGV to Help MedTech Teams Supercharge Regulatory Submissions