Clinical Pharmacovigilance (PV) Auditing Services
We are the Experts You Need for Clinical Pharmacovigilance
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Pharmacovigilance (PV) Audits are tedious, but necessary. They are designed to validate the correctness and effectiveness of the application and operation of a PV system, including its quality control system.
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When supported with Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), audits confirm that trials and services are dependably conducted and controlled according to quality standards.
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At Gemini Group, we have committed and experienced auditors to conduct audits and mock inspections that meet all of your PV program and safety data needs.
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Our PV audits cover the whole gambit of a robust PV system (case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.).
Gemini Group’s PV auditing services review compliance to applicable United States FDA and Europe EMA regulations, guidelines, and standards; third-party agreements; specifications; protocols and policies; standard operating procedures; and work instructions.
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We are the ideal PV audit service provider for many medium and small pharmaceutical companies in which our team performs (remote and on-site) audits on behalf of our clients each year. We have served and maintained long-term relationships with clients across the USA, Canada, Japan, South Korea and Europe.
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Our global and diverse team of compliance consultants possesses a broad knowledge of the regulatory GxP spectrum including GMP, GCP, GLP, GVP, General Data Protection Regulations (GDPR), Medical Device, and Computer System Validation.
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Wide-ranging Foundation of Experience for Clinical Auditing
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Clinical or pre-marketing PV auditing may be part of your obligatory GCP or clinical Quality Assurance (QA) audit activities.
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Our auditors help recognize challenges for the PV system and recommend a consistent and comprehensive pharmacovigilance integration plan to help prevent problems while coordinating PV systems.
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Our subject matter experts understand that auditing—both mock inspection and surveillance auditing—is paramount to the success and regulatory compliance of your product development, commercial program, and quality systems, as well as to the health and safety of the patient or consumer.
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We have an intimate understanding of global regulations and have a diverse range of technical expertise to address any need that comes our way. We take pride in our comprehensive regulatory compliance experience and can tackle the wide variety of needs for pharmaceutical, biologics, medical device, compounding pharmacy, and dietary supplement companies.