Pharmacovigilance

GVP Audits & Regulatory Agency Inspections

Always be GVP inspection ready

Regulatory agencies (including FDA, Health Canada, MHRA, and EMA) can conduct an inspection at any time in your product’s life cycle. They might inspect you during your clinical trial, during the regulatory review/approval process, or after your product is on the market.

That is why we recommend that you always be inspection-ready. Plan and perform mock or self-inspections, conduct a thorough gap analysis before the regulatory agencies show up. If you do not have the time, knowledge, or resources to prepare for and navigate an agency inspection, we can help.

Ensure No Findings at Your Next GVP Inspection

Our experienced auditors conduct pharmacovigilance system audits designed to assess compliance with regulatory pharmacovigilance obligations and inspection readiness of the Client’s procedures, systems, personnel, and facilities.

Managing GVP Inspections to Successful Outcomes

We prepare our clients for routine Good Pharmacovigilance Practices (GVP) inspections, as well as ‘for cause’ pharmacovigilance inspections by regulatory authorities, and provide post-inspection assistance. Our expert auditors also guide organizations going through follow-up inspections for identified non-compliance issues by establishing corrective and preventive action plans and periodic progress reports, as required.

100 % of the regulatory GVP inspections that we supported for clients resulted in compliant ratings. In the past 5 years, our clients' track record includes - no major or critical observations.

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Be Certain in the Ever-Changing PV Landscape

We understand how challenging it is to manage your products' safety risks and deliver customized PV solutions throughout the duration of their lifecycle. We provide you with the certainty that your pharmacovigilance needs are addressed comprehensively and proficiently. Our team of highly dedicated and experienced PV professionals ensures the fulfillment of your regulatory requirements through sound processes and efficient systems.