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:
Our deep understanding of French and European regulations ensures smooth and efficient market entry.
Comprehensive Services:
From MA dossier management to sales force certification, we offer a full spectrum of services to support your product lifecycle.
Strong Regulatory Relationships:
Our established connections with ANSM, HAS, and CEPS streamline the approval and reimbursement processes.
Commitment to Quality:
We uphold the highest standards of product safety, efficacy, and compliance.
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 named AP2 or Accès Précoce post-AMM
unlicenced products:
- Early access program named AP1 or Accès Précoce pré-AMM
- Recommended for Compassionate access programs (AAC)
Why Choose Us?
Choosing Clinigen Healthcare France as your exploitant provides numerous advantages, and we stand out as a leader in the French pharmaceutical market for several reasons:
UNMATCHED EXPERTISE | We are recognized 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, minimizing risks and maximizing efficiency. |
INNOVATIVE SOLUTIONS | We provide cutting-edge, tailored solutions that meet the unique needs of each client. |
STRATEGIC PARTNERSHIPS | Our strong relationships with key regulatory authorities enhance our ability to navigate complex regulatory environments effectively. |
ONE-STOP-SHOP | Offering comprehensive Exploitant services, including Regulatory, Pharmacovigilance, and all associated services under one roof, eliminates the need for sub-contracting. |
PROVEN TRACK RECORD | Successfully managing multiple products for various clients, demonstrating our capability to handle complex regulatory landscapes. |
CLIENT-CENTRIC APPROACH | Customized solutions and proactive communication ensure that client needs are consistently met. |
Our Services
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 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 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 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.