While we are specialists in Rare Diseases, Orphan Drugs and Oncology, our expertise spans all therapeutic areas. As your trusted partner, we streamline processes and accelerate access —wherever you are in the product lifecycle.
What is an Exploitant?
An exploitant is a key player in the French pharmaceutical market, responsible for the commercialization and distribution of medicinal products. This role includes ensuring compliance with regulatory standards, maintaining product quality, and handling all aspects of pharmacovigilance and medical information.
Regulatory Expertise:
With our deep understanding of French and European regulations we ensures smooth and efficient market entry for your products. Our expertise guarantees compliance at every stage of the process.
Comprehensive Services:
From MA dossier management to sales force certification, we offer a full spectrum of services to support your product lifecycle ensuring every step is covered, from regulatory approvals to market launch.
Strong Regulatory Relationships:
Our well-established connections with ANSM, HAS, and CEPS streamline the approval and reimbursement processes, ensuring your product gets to market quickly and efficiently.
uncompromising Commitment to Quality:
We uphold the highest standards of product safety, efficacy, and compliance, so you can be confident that your product will meet all regulatory requirements and reach the market successfully.
Why and when you need an Exploitant?
commercial products:
- After marketing authorisation granted by EMA or national authority with the final reimbursement status.
- After marketing authorisation but before reimbursement and distributed in France through a specific Early access program (AP2 - Accès Précoce post-AMM)
unlicenced products:
- Early access program (AP1 - Accès Précoce pré-AMM)
- Recommended for Compassionate access programs (AAC)
Choosing Clinigen Healthcare France as your Exploitant means partnering with a French pharmaceutical market leader known for efficiency, reliability, and expertise.
As Your Partner of Choice, We Optimise Your Access to the French Market—Simplifying Every Step, from Regulatory Approvals to Market Launch. As part of the wider Clinigen Group, Clinigen Healthcare France can also ensure the compliant distribution and supply of your product.
ONE-STOP-SHOP | Clinigen Healthcare France offers comprehensive services, including Exploitant, Regulatory oversight, Pharmacovigilance, Distribution, and Supply, for your pre-approved and commercial products, all under one roof, eliminating the need for subcontracting. |
FROM RARE TO BROAD: ACCELERATING ACCESS FOR ALL THERAPIES | We are recognised experts in rare diseases, orphan drugs, and oncology—but our capabilities go far beyond. As your end-to-end partner, we simplify and accelerate your product’s path to the French market, whatever the therapeutic area or development stage. |
UNMATCHED EXPERTISE | We are recognised as the foremost experts in regulatory affairs and market access. Our deep understanding of French regulatory requirements and extensive experience as an Exploitant provide unmatched reliability and competence. |
RIGOROUS COMPLIANCE | We ensure strict adherence to all regulatory standards and guidelines, minimising risks and maximising efficiency. |
strategic partnerships | Our strong relationships with key regulatory authorities, such as the ANSM, enhance our ability to navigate complex regulatory environments effectively. |
innovative solutions | We provide cutting-edge, tailored solutions that meet the unique needs of each client. |
PROVEN TRACK RECORD | Successful management of multiple products for various clients demonstrates our expertise to handle complex regulatory landscapes. |
CLIENT-CENTRIC APPROACH | With customised solutions and proactive communication, we ensure your needs are always met. |
EARLY ACCESS | Clinigen Healthcare France and our Exploitant services work seamlessly with our Early Access team in France - supporting, coordinating and navigating the early access authorisation process. |
Our Services
Our expert team manages the full life cycle of MA dossiers, ensuring compliance with all regulatory requirements from initial submission through post-approval maintenance. This comprehensive service includes dossier updates, renewals, and variation submissions, ensuring uninterrupted market presence.
Pharmacovigilance (PV)
At Clinigen Healthcare France, we excel in providing robust pharmacovigilance services. With the support of our mother company, our PV team ensures the continuous monitoring, detection, assessment, and prevention of adverse effects associated with medicinal products.
Medical Information (MI)
At Clinigen Healthcare France, we excel in providing robust medical information services. With the support of our mother company, our MI team offers precise and reliable information to healthcare professionals and patients, ensuring safe and effective use of medications.
Our European Distribution Centre is capable of any delivery: whether it’s large-scale deliveries of commercial packs or small, targeted shipments for named patient programs.
Advanced Logistics Solutions: Our logistics infrastructure supports efficient distribution and storage, ensuring the integrity and quality of our products.
Clinigen Healthcare France excels in managing the supply chain to ensure a consistent and reliable supply of pharmaceutical products throughout France. We adhere to the stringent requirements set by ANSM (French National Agency for Medicines and Health Products Safety) for stock management and safety stocks. Our capabilities include:
- Efficient Stock Management: We maintain optimal inventory levels to meet market demands, avoiding shortages and ensuring timely availability of products.
- Safety Stock Compliance: We comply with ANSM's safety stock regulations to ensure that a backup supply is always available, minimizing the risk of product shortages.
- Batch Recall Management: In the event of a product recall, we have robust procedures in place to execute recalls swiftly and efficiently, ensuring patient safety and regulatory compliance.
We maintain strategic partnerships with key French regulatory bodies, ensuring seamless compliance and expedited approvals:
- ANSM (French National Agency for Medicines and Health Products Safety): We collaborate closely with ANSM to meet stringent safety and efficacy standards for all our products.
- HAS (High Authority of Health): Our engagement with HAS ensures alignment with national health priorities and guidelines.
- CEPS (Economic Committee for Health Products): We can support negociation with CEPS to achieve favorable pricing and reimbursement conditions for our products.
Clinigen Healthcare France is proud to have a certified and highly skilled sales representatives. Our certification ensures that our sales team are well-trained and fully compliant with industry standards and regulations. This enables us to effectively promote and distribute your pharmaceutical products across the French market.
Our thorough review process ensures all advertising materials comply with regulatory guidelines and ethical standards. We ensure that all promotional content accurately represents your products, meeting all necessary legal requirements.
We offer dedicated RPV and EU QPPV services, ensuring that all pharmacovigilance activities are conducted in compliance with European Union regulations. Our qualified experts oversee safety monitoring and reporting, maintaining the integrity of your product's safety profile.
We specialize in the preparation and submission of reimbursement dossiers, facilitating market access and patient affordability:
- Reimbursement List : We ensure your products are included on national reimbursement lists, enhancing accessibility and affordability.
- Our team navigates the complex community approval processes, securing endorsements for widespread use.