Specialising in Rare Diseases, Orphan Drugs, and Oncology, We Optimise processes to Make Access Simple and Fast—No Matter Where 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.
Which products require 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)
Why Choose Us?
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.
ONE-STOP-SHOP | Offering comprehensive Exploitant services, including Regulatory, Pharmacovigilance, and all associated services under one roof, eliminates the need for sub-contracting. |
orphan & rare diseases | We specialise in rare diseases, orphan drugs, and oncology therapies, ensuring your product reaches patients efficiently—at any stage of development. As the partner of choice, we streamline your journey to the French market with:
|
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 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. |
Our Services
- Managing Medical Information Enquiries
- Batch follow-up and recalls serialisation
- Safety stock management (MITM)
- Complaints and requests
- Promotional activities and sales rep certification
- Quality Management System
- Regulatory intelligence and compliance
- Wholesale distribution
- Subcontractor and manufacturer oversight
- MSL activities
- Local Pharmacovigilance & AE management
- Tender management
- Key point of contact for health authorities
- Preparation and submission periodic reports
- Preparation and submission of Protocol
- Labelling
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.
We specialize in the preparation and submission of reimbursement and European approval dossiers, facilitating market access and patient affordability:
- Reimbursement List : We ensure your products are included on national reimbursement lists, enhancing accessibility and affordability.
- European Approval: Our team navigates the complex community approval processes, securing endorsements for widespread use.
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.
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.
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.
- Advanced Logistics Solutions: Our logistics infrastructure supports efficient distribution and storage, ensuring the integrity and quality of our products from manufacturing to delivery.
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.
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.