About Essenvia
Why we exist
Incumbent regulatory systems are repositories — they store. But the real work of regulatory affairs is keeping products legally sellable: registering them, renewing them, assessing every change, and knowing exactly where each one stands, in every market. Founded in 2018 in Los Angeles, Essenvia set out to run that work — product-first, AI-native, and honest about what the technology can and can’t do. Today, enterprise and mid-market medtech teams trust Essenvia to keep their portfolios sellable and audit-ready.
A system of record for regulatory work
What we believe
Foundation first
Get the data right before you automate it. Clean, structured regulatory data is the foundation everything else stands on — so we start there, every time.
Humans lead, AI accelerates
Our AI drafts, extracts and monitors at speed — but a regulatory professional is in the loop at every step. AI enhances judgment; it never replaces it.
Accountability earns trust
We hold ourselves — and our customers — accountable, with named owners, acceptance criteria, and a published implementation methodology. Confidence, not promises.
Meet you where you are
We coexist with the systems you already run. Start with one workstream, prove the value, and expand — no rip-and-replace.
Regulatory is revenue
We treat regulatory as what it really is: the function that protects a company’s ability to sell. Not a cost center — a revenue enabler.
2018
Founded
LA + Bengaluru
Two offices, two continents
SOC 2 Type II
Independently audited
Medtech-first
Built for medical device & life sciences
Leadership
Soumya Mahapatra
Co-founder & CEO
Soumya co-founded Essenvia in 2018 with a conviction the industry had underweighted: regulatory affairs isn’t documentation — it’s what keeps a company’s products legally sellable. He leads Essenvia’s vision, product direction, and the partnerships with the enterprise medtech teams that run their regulatory operations on the platform.
Basant Sahoo
Co-founder & CTO
Basant co-founded Essenvia in 2018 and leads engineering and AI. He is responsible for the platform’s architecture and its AI-governance program — the human-in-the-loop controls, explainability, and data isolation that let regulated teams trust AI with high-stakes submissions.
Advisors
Kwame Ulmer — Board Member
Former FDA Deputy Director & Branch Chief
Kwame spent 12 years at the FDA in progressive leadership roles including Deputy Director and Branch Chief, personally evaluating more than 1,000 medical technologies. He later led Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher company, and founded MedTech Impact Partners.
Security and trust, proven — not claimed.
SOC 2 Type II, independently penetration-tested, and reviewed against OWASP Top 10 for LLM, with a formal AI-governance program.
Who we serve
From mid-market manufacturers to global enterprises running submissions across dozens of markets — medical-device and life-sciences regulatory teams run the work on Essenvia, alongside the systems they already have.
Mid-market manufacturers
Global enterprises
Multi-division portfolios
Multi-market submissions
Book a walkthrough on data like yours, or talk to our team.
