GCP & PV Inspection Readiness/Audit
Ensuring Compliance, Data Integrity & Patient Safety
Supporting Compliance, Data Integrity & Patient Safety
We help you achieve GCP and PV inspection readiness, supporting full compliance with global regulatory requirements. Our focus is on the rights, safety, and well-being of trial participants while maintaining the integrity of clinical and safety data. By preparing your team and processes for inspections, we support accurate recording, processing, and maintenance of critical information—helping you navigate regulatory reviews with confidence.
Our GCP and PV Inspection Readiness/Audit lead
Helen Powell
Pharmacovigilance and GCP Consultant, Quality Assurance
Comprehensive GCP & PV Inspection Readiness/Audit Services
Inspection Preparation & Training
- GCP & PV Inspection Support – Expert guidance to support compliance with global regulatory expectations.
- Inspection Readiness Training – Tailored training programs to prepare teams for regulatory inspections.
- Remote & On-Site Preparation – Hands-on support for sponsors, MAHs, investigator sites, and vendors.
Inspection Execution & Post-Inspection Support
- Mock Inspections – Simulated inspections to identify gaps and enhance preparedness.
- On-Site & Remote Inspection Support – Expert assistance during regulatory inspections.
- Post-Inspection Response Support – Review and guidance on regulatory responses and follow-up actions.
Audits, Risk Analysis & Compliance Strategy
- GCP & PV Audits – Conducting comprehensive audits to assess compliance readiness.
- PV & GCP Gap Analysis – Identifying and addressing compliance gaps to mitigate risk.
- Risk-Based Audit Strategy – Developing a proactive approach to risk-based auditing.
- PV Risk Assessments – Evaluating pharmacovigilance risks and mitigation strategies.
- CAPA Remediation – Corrective and preventive action (CAPA) planning and implementation.
ICH GCP E6(R3)
- ICH GCP E6(R3) – A game changer for those working in clinical trials.
- R3 – A fit for purpose, adaptive framework.
- Online training modules or bespoke – Join our training sessions and apply ICH GCP E6(R3) with confidence.
- Taster webinar – Check out our sample taster webinar here.
