Launching in France without a French Affiliate? See how this biotech did it — with Elliogen.
The Challenge
A US-based biotech company developing a rare disease treatment wanted to enter the French market.
But France has a unique requirement: to sell prescription medicines, you need an Exploitant — a licensed entity responsible for regulatory compliance.
Setting up a local subsidiary wasn’t an option. They needed:
✅ A trusted exploitant partner
✅ A compliant regulatory and pharmacovigilance setup
✅ A way to launch fast without sacrificing quality
The Elliogen Solution
Elliogen helped this biotech enter France without delay or detours. Here’s how:
🔎 1. Exploitant Search & Matchmaking
We identified and vetted three exploitant partners with relevant therapeutic experience.
The client selected one with a proven ANSM track record and flexible pricing model.
📄 2. Contract & Compliance Support
We supported all negotiations — from roles and responsibilities to safety reporting obligations.
The contract clearly defined regulatory oversight, QP release, and escalation processes.
🚚 3. Seamless Launch Readiness
We integrated the exploitant into the client’s global supply and safety systems.
We also helped prepare early access submissions and coordinated with the French Medicines Agency (ANSM).
The Results
⚡ Launch-ready in just 4 months
🔒 Zero regulatory issues during post-launch inspection
📄 Early Access Application submitted with full support from the exploitant
💰 No need for a French subsidiary or in-country headcount
“Without Elliogen, we would have spent 12+ months and six figures building infrastructure. Instead, we launched on time and fully compliant.”
— VP Regulatory Affairs, US Biotech
Why It Worked
✅ Speed to market — no time lost building a French entity
✅ Regulatory peace of mind — exploitant fully audit-ready
✅ Flexible market entry — scale without long-term overhead
Ready to Enter France the Smart Way?
Elliogen helps pharmaceutical companies launch in France without delay — connecting you with the right exploitant and guiding you through every regulatory step.
Whether you’re planning early access, full launch, or licensing, we make France easy to enter, easy to navigate, and easy to grow.
👉 Contact us at hello@elliogen.com to get started.