Essenvia runs the regulatory work that keeps your portfolio on the market: registrations, submissions, change control, and the evidence to prove it — alongside the systems you already have.
We work with regulatory teams worldwide
Most regulatory systems were built to store. But the question leadership actually asks isn’t “where is the file?” — it’s “what can we sell, where, right now, and can we prove it?”
Most RIM platforms
Essenvia
File and retrieve documents
Keep every product sellable
Answer the auditor afterwards
Prove it at any moment
Report on what already happened
Act on change before it costs you
Registrations, submissions, change management and regulatory intelligence — connected to the systems you already run.
Trusted by Regulatory Affairs Teams Globally
Run it alongside what you already own
You don’t have to rip out your RIM. Start with limited SKUs, one division and a few markets, running alongside your current process. Reach steady state, then expand SKUs, countries and divisions as the results earn it. Essenvia connects to the systems around it — PLM, eQMS, document control, ERP and file storage — so regulatory work stays seamless.
You’ll know exactly how it goes live
Every implementation runs to our proven playbook: named owners on both sides, written acceptance criteria and defined value milestones. We hold ourselves to it — and we hold you to it, because a system nobody adopts helps no one.
Your IT and validation teams can sign off
SOC 2 Type II, independent penetration testing, AI governance reviewed against the OWASP Top 10 for LLMs, and IQ/OQ/PQ validation documentation — ready before they ask.
Do we have to replace our current RIM?
Initially, teams run Essenvia alongside their existing RIM rather than replacing it, with Essenvia connected to the systems around it — PLM, eQMS, document control, ERP and file storage. Our proven implementation playbook is built to de-risk the rollout: start with limited SKUs, one division and a few markets, reach steady state, then expand SKUs, countries and divisions as the results earn it. You will retire your current RIM system once the rollout is complete.
Is the AI real, or is it autocomplete with rigid form fields?
Real. You author in native Microsoft Word rather than fixed form fields, and the AI has been used on a live PMA — the most demanding submission type — as well as global filings across multiple jurisdictions. A generation report shows exactly what it produced, and a regulatory professional reviews and approves everything before it goes anywhere.
Does it work with Microsoft Word, or a Word-like editor?
Real Microsoft Word. Your team authors in the tool it already uses, with formatting and tracked changes intact.
What does it integrate with?
PLM, eQMS, document control, ERP (including SAP) and file storage, bi-directionally. Integrations are proven in production, not roadmap.
What happens to our existing regulatory data?
It comes across through a structured migration, with AI-assisted extraction and enrichment validated against health-authority sources. Essenvia then connects to the systems you are keeping, so data continues to flow both ways.
How is it priced?
By the shape of your footprint — modules, product volume, markets and users — quoted in clear bands rather than a formula you cannot predict.
Backed by
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