Having successfully supported 300 inspections requested from 39 Regulatory Authorities in Europe, the US and Canada, our QA team guarantee inspection readiness.
We provide a clear path to maintaining compliance in the face of increasing regulatory scrutiny. Through our QbD approach based on data integrity, scientific evaluation of risks and effective communication, we prepare our clients for routine Good Pharmacovigilance Practices (GVP) inspections, as well as ‘for cause’ PV inspections by regulatory authorities and third-party vendors/partners.
Our QA experts steer organizations through follow-up inspections for identified non-compliance issues by establishing Corrective and Preventive Action (CAPAs) plans and periodic progress reports, as required. We provide post-inspection assistance and prepare SMART (Specific, Measurable, Achievable, Realistic, Time-driven) responses.
Our experienced PV experts and trainers help clients to:
- Audit and make recommendations to improve an existing PV system
- Implement and validate a new PV system
- Develop and validate Standard Operating Procedures (SOPs)
- Provide initial ongoing PV Training for all staff
- Broker PV Agreements with partners and vendors
- Audit and support Computerized Systems Validation (CSV), carried out according to the industry standard GAMP5 (2nd ed.)
- Develop the whole cycle of a system from planning to operation through QaaS (Quality as a Service)
- Ensure that the PV system and PSMFs are inspection ready
- Develop and manage clients’ audit universe.