Coming up · 15–17 September
Keep every product legally sellable.
How Regulatory Teams Scale for Business Integration & Remain Audit-Ready
Event
RAPS Convergence 2026
Session
Wed 16 Sept · 12:30–12:55 pm
Exhibit Hall
Ignite! Theater Booth 1126
Location
Charlotte, NC
The session
Most regulatory platforms were built to store data. Integrating a business unit is a different challenge.
Medtech runs on acquisition, consolidation and divestiture — and every one of those decisions hands regulatory another portfolio to integrate, usually on a short, board-committed timeline. The sequence below is drawn from Terumo Medical Corporation’s integration efforts, where products flowed in from SAP. This is what it actually takes, in the order it has to happen.
Days 0–30
Name the people before the systems
Integrations stall on ownership, not technology. Name a sponsor who can settle escalations and budget, a systems lead — a champion — for the ERP and the RIM, and an admin team of super users on the acquired side who already know the process. Champions are how others buy in.
Days 0–30
Inventory before you decide anything
What you actually inherited: registrations, markets, evidence, expirations. Most teams start harmonizing before they know the shape of what they took on — and redo the work.
Days 0–30
Settle the system decisions harmonization depends on
Which regulatory system of record wins, who owns the change, what data has to move and what can be referenced where it sits — before anyone touches a record.
Days 30–60
Drive change management through wins
Continuous training, repeated conversations, and demonstrating value through audit wins. The RIM actively used for change management — reports to track product and country-level changes helps shift mindset.
Days 30–60
Switch on the integration that carries the load
Often it is one connection, not a suite. When products sync automatically out of the ERP that already holds them, an acquired catalog arrives without re-keying — the difference between a quarter and a year.
Days 60–90
Decide what to leave alone in year one
The most under-discussed part of any integration. Some things shouldn’t be harmonized yet — and the rest doesn’t have to move at once. Bulk-load submissions and licenses first, then stage the remainder, so nothing stops being sellable mid-migration.
What you’ll take away
Four things you can use the week you get back
Recognize why growth and integration strain regulatory teams — and why a system that only stores data can’t integrate a new business unit at speed.
Describe how one harmonized system plus an ERP integration that actually works let a team bring in an acquired division and double its portfolio without changing process or ripping out tools.
Apply practices that keep every product sellable and audit-ready across markets as the business scales — turning regulatory into an accelerator of M&A, not a bottleneck.
Reframe regulatory to leadership as a guardian of sellability and revenue and an integration enabler — not a cost center.
Who’s presenting
Soumya Mahapatra
Soumya Mahapatra
Founder & CEO, Essenvia
Founder and CEO of Essenvia, with 21 years leading complex digital transformation. They specialize in the implementation and adoption of AI and automated regulatory technology across the medtech and healthcare industry.
Take it with you
The Regulatory AI Playbook
How regulatory teams adopt AI without losing control of it — the maturity model, the governance framework, and a readiness assessment you can run on your own function.
An adoption maturity model for regulatory AI
The human-in-the-lead governance framework
A readiness assessment for your own function
Where AI earns its place — and where to stay cautious
Drawn from enterprise medtech deployments
Get the AI Playbook
We’ll be in Charlotte for all three days
If you’re integrating a portfolio right now — or about to be — it’s worth an hour away from the show floor. We’ll go through the sequence against your own situation, not a deck.
Get the AI Playbook
The maturity model, the governance framework, and a readiness assessment you can run on your own function.