Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
Exploitant pharmaceutical site consulting services
What is an exploitant pharmaceutical site?
The "exploitant" is a status applied in France to companies performing commercial activities related with medical products. These activities include the wholesale and distribution free of charge of medicines, advertising, information, pharmacovigilance, batch follow-up, and if required, batch recall operations, as well as the corresponding storage activities.
Our services for exploitants cover :
- Preparation of dossiers for the opening license of a pharmaceutical company in France
- Preparation of dossiers for the modification of a pharmaceutical company in France
- Establishment of the company quality management system (SOPs, quality indicators...)
- Submission of the license application to the authorities
- Follow-up of the dossier and response to the Authorities
- Pharmacovigilance services, including EU QPPV and local QPPV
- Local contact for pharmacovigilance
- Management of the local pharmacovigilance
- Medical information services
- Qualified person deputy in France
- Preparation of the Site Master File
- Preparation for regulatory inspections
- Conducting audits
- Charter for pharmaceutical promotion
- DMOS (French gift law) and transparency of interests
- Preparation of new procedures (SOPs) and updating existing ones
- Preparation of Technical Agreements
- Evaluation of Product Quality Reviews (PQR)
- Price and reimbursement (generics)
- Interaction and meetings with the French Authorities (ANSM, CEPS, HAS…)
- Advice and interpretation of the French regulations
Do you want to create a licensed pharmaceutical company in France ?
AxeRegel can assist you in planning and creating a licensed pharmaceutical company in France (exploitant status).
Our support includes the preparation of the dossier for the opening license of a pharmaceutical company, the establishment of the quality management system (SOPs, quality indicators ...), the submission of the license application to the authorities, the follow-up of the dossier and the response to the Health Authorities.
AxeRegel can also provide you with the services of a Qualified Person deputy and a local responsible person for Pharmacovigilance and an EU QPPV.
AxeRegel can assist you in opening of a licensed pharmaceutical company in France
The exploitant Chief pharmaceutical officer
In France, any company with at least one pharmaceutical establishment must be owned by a pharmacist or a company whose management or general management includes a pharmacist (article L5124-2 CSP). These pharmacists are called Pharmacien Responsable.
The Responsible Pharmacist in an exploitant pharmaceutical company has a statutory position which covers broader responsibilities than those of the Qualified Person (QP) under the current European Union system.
The Qualified Person is a privileged function in France. Placed at the heart of the board of directors of the French pharmaceutical companies, the QP accumulates several responsabilités and is the privileged interlocutor of the Health authorities. The Qualified Person is the guarantor of the respect of the French Health Code (CSP) inside the pharmaceutical company, and more generally, of medicines' safety.
The Qualified Person (the exploitant Chief pharmaceutical officer) organises and supervises all the pharmaceutical operations of the company (article R. 5124-36 CSP).
Activities under the responsibility of the exploitant Chief pharmaceutical officer in France
- The manufacture, promotion (publicity and training of the medical sales visit), medical Information, pharmacovigilance, batch follow-up (including the management of complaints, batch recalls, etc.), distribution (including transport conditions), importation and exportation of the concerned medicines, products, objects or articles as well as the correspondent storage operations and labelling operations.
- The Qualified Person in France signs the Marketing Autorisation applications (MA) submitted by the company and any other requests related to the pharmaceutical activities.
- France Qualified Person participates in the preparation of the research and study program.
The exploitant Chief pharmaceutical officer
Discover the role and duties of the" exploitant" Chief Pharmaceutical Officer, France Qualified Person here.
The exploitant Qualified Person deputy
The pharmaceutical company appoints, at the same time as the Responsible pharmacist, one or more interim Responsible Pharmacists (art. R. 5124-23 CSP).
Indeed, in case of temporary absence or ban on practicing, the Qualified Person must be replaced by a Qualified Person deputy (called Pharmacien Responsable Intérimaire).
The Qualified Person deputy (QP deputy):
- Replaces the Qualified Person during the latter's absences.
- Has the same powers and attributions as those conferred to the QP during the whole replacement period.
- May perform his/her duties as a consultant or employee of the company.
- Does not have a corporate mandate.
His/her entry into function is subject to validation by the French Chamber of Pharmacists.
During the replacement, the Interim Responsible Pharmacist (QP deputy) devotes himself exclusively to this activity.
Learn more about the role and duties of the" exploitant" Chief Pharmaceutical Officer deputy, the French Qualified Person deputy here.
What can we do for you today? A QP deputy?
AxeRegel can provide you with the services of a Qualified person deputy in France.
AxeRegel wide range of services to exploitants include the following:
Medical Information Services
At AxeRegel we provide a 24/7 medical information service.
We handle all medical information requests regardless of the channel they arrive in and answer to questions from healthcare professionals and patients.
We provide support in the preparation of Frequently Ask Questions (FAQs) and monitor the update of SmPCs.
Clients are informed about each question handled by e-mail.
Reconciliation of medical information queries is performed monthly.
Would you like to delegate part of your pharmacovigilance obligations or do you need occasional support for a specific task? Do you need a one-off expert opinion or do you need to outsource completely the handling of your pharmacovigilance cases, your literature review or the drafting of a periodic safety report?
We offer you a scientific expertise adapted to your needs and projects.
Regulatory Affairs Services
Regulatory Affairs comprise several activities that go from the submission of a Marketing Authorization application of a medicine to it's post-approval lifecycle maintenance, passing through the validation of packaging material and of Product Information.
At AxeRegel we are at your side to help you find the solution to your needs.
Quality Assurance services
Quality Assurance covers all aspects that could have an impact on the quality of pharmaceutical products during their development, manufacturing, and commercialisation steps.