Regulatory bodies such as the FDA, Health Canada, MHRA, and EMA retain the authority to conduct inspections at any point in your product’s lifecycle. These evaluations may occur during clinical trials, regulatory review, or post-market phases.
To ensure readiness for these inspections, we advise continuous preparation. This includes organizing mock or self-inspections and conducting comprehensive gap analyses before regulatory agencies initiate visits. Should you lack the time, expertise, or resources for this preparation, our assistance is available to help you navigate and prepare for regulatory inspections effectively.
Ensure Compliance and Success at Your Next GVP Inspection
Our seasoned auditors specialize in conducting pharmacovigilance system audits tailored to evaluate adherence to regulatory pharmacovigilance obligations and the readiness of your procedures, systems, personnel, and facilities for inspection.
Guiding You to Successful GVP Inspections
We equip our clients for both routine Good Pharmacovigilance Practices (GVP) inspections and ‘for cause’ pharmacovigilance inspections initiated by regulatory authorities. Additionally, we offer post-inspection support. In instances of identified non-compliance, our expert auditors assist organizations in establishing corrective and preventive action plans, providing periodic progress reports as necessary.
Benefits of Pharmacovigilance Auditing and Inspection Readiness:
Pharmacovigilance and audits offer numerous advantages, including:
Improved Compliance:
Regular audits and preparation for inspections bolster adherence to pharmacovigilance regulations and guidelines, thereby mitigating the likelihood of regulatory actions and penalties.
Enhanced Data Quality:
Through audits, discrepancies and inconsistencies in data are pinpointed, resulting in heightened data quality and reliability.
Proactive Risk Management:
Inspection readiness strategies empower organizations to anticipate and mitigate potential risks, enabling proactive measures to address any deficiencies uncovered during inspections, thus minimizing their impact
