Solutions

Our Solutions

Where innovation meets
opportunity for patients in Europe.

We offer Biopharmaceutical companies committed to addressing unmet medical needs in rare and serious diseases flexible strategic partnerships for the direct commercialization of their first pharmaceutical product in Europe.

Solutions

Our Solutions

Where innovation meets
opportunity for patients in Europe.

We offer Biopharmaceutical companies committed to addressing unmet medical needs in rare and serious diseases flexible strategic partnerships for the direct commercialization of their first pharmaceutical product in Europe.

Join the Expert Q&A Series

Critical Knowledge. Real Experts. Your Questions.

Get access to concise, high-impact PDFs where our industry veterans distill decades of experience to help you navigate Europe’s complex biotech and pharma landscape.

Each edition focuses on the critical knowledge you need—from regulatory hurdles to post-approval strategy—so you avoid costly missteps and move
forward with clarity.

You’re not just reading—you’re part of the dialogue. Each edition is shaped by questions from our community, and you can submit your own for future
Q&As.
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Buy

Acquire a Ready-to-Operate Exploitant Structure.

A turnkey solution to accelerate setup and immediate alignment with French regulatory requirements.
Acquire a fully compliant, ready-to-operate Exploitant entity.

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Your Goal

Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.

Our Solution

  • A fully compliant ANSM-authorized Exploitant entity, ready for immediate deployment.
  • Streamlined acquisition process with due diligence support to ensure a smooth transition and operational readiness
  • Existing QMS, SOPs, and infrastructure in place—minimizing setup time and regulatory risk
  • Optional provision of a Pharmacien Responsable and core operational team to support your launch
  • Ideal for companies seeking long-term presence in France without the delays of building an Exploitant from scratch or looking to derisk market entry in France

Understanding the Role of the Exploitant

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This legally designated entity is responsible on the French market for:

  • Ensuring Regulatory Compliance
  • Supervising Batch tracking and recalls
  • Overseeing Medical information
  • Overseeing Pharmacovigilance
  • Managing Advertising/promotional material compliance
    incl. Charter on information provided for the promotion of medicinal products through prospecting or canvassing

 

 

 

The Exploitant’s responsibilities are supported by a dedicated organization and Quality Management System (QMS), which must ensure ongoing compliance and inspection readiness.

The designated site is regularly inspected by the ANSM, and the QMS must cover all processes related to the Exploitant’s operations and regulatory obligations.

The Exploitant is required to appoint a Pharmacien Responsable(Chief Pharmaceutical Officer), who holds personal and legal accountability for the company's pharmaceutical activities and compliance with French pharmaceutical regulations..

To obtain Exploitant status, a company must submit a comprehensive dossier to the ANSM, detailing the organizational structure, quality systems, and procedures in place to manage the responsibilities outlined above. This includes information about the appointed Pharmacien Responsable, facilities, and any subcontracted activities. The process requires meticulous preparation and a deep understanding of French regulatory expectations.

 

Exploitant responsibility in France:

Choose from our 3 flexible models

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Your Goal
Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.
8
Your Goal
Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.
8
Your Goal
Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.
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Establishing a commercial subsidiary in France is a time-consuming and resource-intensive process that can take up to 18 months.
It demands substantial local expertise, internal resource allocation, and local recruitment, even for part-time roles, to set-up and organize an ANSM-authorized Exploitant structure.
Companies with little or no initial presence in France are seeking customized solutions to rapidly establish their own Exploitant subsidiary for a swift business start, particularly to accelerate launch of their first product through an early access program.

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Your Goal
Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.

 

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Looking to enter the EU market?
Contact us today.

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