Confidence Beyond Compliance
Achieving a state of permanent inspection readiness is the ideal scenario for any pharmaceutical organization. Specifically for virtual organisations, a robust and effective Pharmaceutical Quality System and vendor management programme is critical, as well as monitoring its ongoing effectiveness and suitability through periodic GxP Audit and Quality Management review. To prepare organizations, both virtual and in-house, for regulatory inspections in many of the major pharmaceutical and medical device markets including USA, Canada, Europe, and Asia, PharmaLex’s Inspection Readiness services includes:
- Gap analyses
- Third Party Audits
- Mock Inspections (conducted by a former regulatory inspector)
- Self-Inspection Support
PharmaLex will review the QMS and compare it to the elements of a QMS that are mandated and/or recommended by regulatory authorities such as US, EU, LATAM, APAC and Russian agencies, as well as the International Conference on Harmonization (ICH) and World Health Organization (WHO) as applicable.