Exploitant - Pharmaceutical Establishment
How to open or find your “Exploitant" pharmaceutical company in France?
Opening of “Exploitant” pharmaceutical company
- Administrative support (commitment letters from the responsible pharmacist, KBIS, premises plans, etc.)
- Writing the technical note
- Provision of a deputy Responsible Pharmacist (PRI)
- Preparation of electronic submission to the Authorities
- Monitoring and response to the Authorities
- Creation of the QMS (writing, review of procedures)
- Support in setting up your contracts (head office, providers)
- Advisory support for the opening of the establishment
Find an “Exploitant” pharmaceutical company to whom you can entrust the exploitation of medicinal products for France
- Presentation/explanation of French requirements
- Contact with Authorized “Exploitants” in France
- Drafting contracts/agreements
- Identification of crucial points to be agreed
- Definition of a retro-schedule
Prepare the French Site master file
- Advisory support
- Compilation of the document
Closure of “Exploitants”
- Business continuity
- Impact analysis on the pharmaceutical activities of the site with regard to regulatory obligations within the meaning of the French Public Health Code
- Identification of key regulatory elements enabling the establishment to comply with its applicable obligations after closure
- Support in closing pharmaceutical activities and/or formalizing handovers in line with the Exploitant’s regulatory requirements
- Advisory support on the transfer of activities between two “Exploitant” in terms of pharmaceutical responsibility
- Preparation of transfer letters between Responsible Pharmacists
Further information
Atessia will be your partner for all the procedures involved in opening or finding an “Exploitant” pharmaceutical company in France.