Exploitant - Pharmaceutical Establishment

How to open or find your “Exploitant" pharmaceutical company in France?

  • 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
  • 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
  • Advisory support
  • Compilation of the document
  • 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

Download the document "Les activités d'Exploitant pharmaceutique"

Atessia will be your partner for all the procedures involved in opening or finding an “Exploitant” pharmaceutical company in France.