Clinical Pharmacovigilance (PV) Auditing Services

The Expertise You Need for Clinical Pharmacovigilance

Pharmacovigilance (PV) Audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system.

When aligned with Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), audits ensure that trials and services are consistently conducted and controlled according to quality standards.

At ProPharma Group, we have dedicated and knowledgeable auditors to conduct audits and mock inspections that meet all of your PV program and data needs.

Our PV audits cover the whole 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.). ProPharma 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.

We are the preferred PV audit service provider for many large and small pharmaceutical companies where our team performs over 100 (remote and on-site) audits on behalf of our clients each year. We have served and maintained long-term relationships with more than 400 clients across the USA, Canada, Japan, and Europe.

Our global 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.

Broad Foundation of Knowledge for Clinical Auditing

Clinical or pre-marketing PV auditing may be part of your required GCP or clinical Quality Assurance (QA) audit activities.

Our auditors help identify challenges for the PV system and advise for a proper pharmacovigilance integration plan to avoid problems while harmonizing PV systems.

Our consultants understand that auditing—both mock inspection and surveillance auditing—is critical 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.

We understand global regulations and have a diverse range of technical and regulatory compliance experience that can address the wide variety of needs for pharmaceutical, biologics, medical device, compounding pharmacy, and dietary supplement companies.

Contact Us

Need Help Managing Your Drug Safety Requirements?

Contact us to learn how our clinical and postmarketing PV services can support your needs on a standalone basis or integrated with global Medical Information and Regulatory services.

Interested in gaining an industry edge? Let us help you stay current.

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