OUR ROLE
Exploitant Laboratory
Intsel Chimos as a “Laboratoire Exploitant ”.
A distinct French responsibility model — and a core part of who we are.
In France, the term “Laboratoire Exploitant” refers to a very specific legal and regulatory status within the pharmaceutical ecosystem. It does not exist in most other countries, which often leads to confusion for international partners.
A Laboratoire Exploitant is not necessarily the manufacturer or the owner of a medicine. Instead, it is the only entity legally responsible for placing the product on the French market, ensuring its continuous availability, quality, safety, and compliance with all regulatory obligations.
Why this status matters
One company, fully accountable for your medicine in France.
For a non-French audience, the best way to describe a “Laboratoire Exploitant” is:
It is the company fully accountable for a medicine once it enters the French healthcare system.
Even if another company manufactures or owns the product, the “Laboratoire Exploitant” is the one ultimately responsible to the authorities
Its responsibilities include:
1. Regulatory compliance (ANSM & Ministry of Health)
2. Pharmacovigilance and patient safety
3. Quality Assurance
4. Storage and distribution
5. Promotion
6. Medical Information
1. Regulatory compliance (ANSM & Ministry of Health)
- ensuring that the product complies at all times with French pharmaceutical regulations
- managing national MA (Marketing Authorisation) obligations or, for non-MA products, all relevant alternative frameworks
- handling all interactions with ANSM (French medicines agency)
2. Pharmacovigilance and patient safety
- monitoring safety signals
- managing risk-minimisation plans
- ensuring 24/7 pharmacovigilance
- managing adverse event cases
3. Quality Assurance
- ensuring that every batch distributed in France meets quality standards
- overseeing the entire supply chain — even if manufacturing or distribution is outsourced
- management of quality complaints and product recalls/batch withdrawals
4. Storage and distribution
This is a particularly French expectation:
The Exploitant is responsible for storage and distribution even if logistics are delegated. Storage and transport conditions must be respected on a case-by-case basis, depending on the product.
Traceablility at all time is the main focus of the Exploitant when it comes to distribution of medicinal products.
The Exploitant must also guarantee product availability and must notify the authorities of any shortage, anticipated or effective.
5. Promotion
- managing the promotion team (KAMs & MSLs)
- validating the promotion material
- complying with the applicable regulations
6. Medical Information
- acting as the scientific reference for the products operated in France
- providing non-promotional medical information to healthcare professionals and institutions
- supporting appropriate and compliant use of medicines in line with approved regulatory frameworks
- contributing to benefit-risk assessment in coordination with MAH
- ensuring medical governance, compliance and ethical standards across all medical activities
OUR MODEL
Intsel Chimos and the Laboratoire Exploitant status
Intsel Chimos first obtained the status of “Laboratoire Exploitant” in 2000, marking an important milestone in the company’s development.
- Strong regulatory expertise, enabling the company to navigate the French framework for complex or highly specialised products
- Robust pharmacovigilance and quality systems aligned with the most stringent standards
- Agility in access frameworks, including early access pathways, compassionate use, and specific hospital-only circuits
- Deep collaboration with hospital pharmacies, essential in areas where continuity of supply is critical
- introduce and maintain high-value, complex, niche, or critical medicines on the French market
- support innovative products in early or transitional access schemes
- ensure patient safety and uninterrupted supply within demanding therapeutic areas
For companies outside France, working with a “Laboratoire Exploitant” like Intsel Chimos means:
- accessing a specialised regulatory and market-access partner
- navigating France’s unique frameworks with a company fully accountable to the authorities
- ensuring compliance with a model that centralises responsibility and patient safety
- benefiting from an experienced actor who manages all obligations from pharmacovigilance to distribution oversight
