Exploitant - Pharmaceutical Establishment

Activities related to Quality

  • Administrative support (letters of commitment from the PR, KBIS, plans of the premises…)
  • Drafting the technical note
  • Creating the QMS (drafting, reviewing of procedures)
  • Follow-up and response to the authorities
  • Providing an Acting Head Pharmacist
  • Electronic submission of the application to the authorities
  • Support and advice on opening the establishment
  • Creating a process map of the operating facility
  • Listing SOPs for opening a pharmaceutical establishment
  • Drafting SOPs
  • Reviewing and improving existing SOPs
  • Reviewing the PQRs summarized in table format
  • Exhaustive proofreading of the QPRs provided by the manufacturers
  • Action plan or comments for the “N” PQR 
  • Action plan or comments for the “N+1” PQR

Further information

Download the document "La Revue Qualité Produit (RQP)"
Download the document "Les activités d'Exploitant pharmaceutique"

Expertise in reviewing PQRs: our team of consultants has reviewed over 100 exploitant PQRs for pharmaceutical products in various formulations.