Our experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
Our services include:
- Advice and operational support for pharmaceutical companies located in France for a quality system that meets regulatory expectations for an “Exploitant” status
- Provision of deputy “Exploitant” QPs (PRI)
- Risk analysis / Process mapping
- Advice, review or preparation of:
- Product Quality reviews (PQR)
- Client-customized SOPs or quality manuals,
- Quality technical agreements
- Application for obtaining the “Exploitant” status from ANSM and annual reports
- Contingency plans for drug shortage (PGP) for medicinal products of major therapeutic interest (MITM)
- Serialization
- Audits of pharmaceutical processes according to GMP, GDP or “Exploitant” activities
- Preparation and support prior to ANSM inspection
