Exploitant - Pharmaceutical Establishment
Activities related to Quality
Opening an Exploitant establishment
- 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
Implementing the quality management system (QMS)
- Creating a process map of the operating facility
- Listing SOPs for opening a pharmaceutical establishment
- Drafting SOPs
- Reviewing and improving existing SOPs
Product Quality Review (PQR)
- 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
Expertise in reviewing PQRs: our team of consultants has reviewed over 100 exploitant PQRs for pharmaceutical products in various formulations.