Launching in France without a French Affiliate? See how this biotech did it β€” 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 β€” a licensed entity responsible for regulatory compliance.

Setting up a local subsidiary wasn’t an option. They needed:
βœ… A trusted exploitant partner
βœ… A compliant regulatory and pharmacovigilance setup
βœ… A way to launch fast without sacrificing quality


The Elliogen Solution

Elliogen helped this biotech enter France without delay or detours. Here’s how:

πŸ”Ž 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.

πŸ“„ 2. Contract & Compliance Support

We supported all negotiations β€” 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
πŸ”’ Zero regulatory issues during post-launch inspection
πŸ“„ Early Access Application submitted with full support from the exploitant
πŸ’° No need for a French subsidiary or in-country headcount

β€œWithout Elliogen, we would have spent 12+ months and six figures building infrastructure. Instead, we launched on time and fully compliant.”
β€” VP Regulatory Affairs, US Biotech


Why It Worked

βœ… Speed to market β€” no time lost building a French entity
βœ… Regulatory peace of mind β€” exploitant fully audit-ready
βœ… Flexible market entry β€” scale without long-term overhead


Ready to Enter France the Smart Way?

Elliogen helps pharmaceutical companies launch in France without delay β€” 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.

πŸ‘‰ Book a Call or Download Our Exploitant Guide to get started.