Good Pharmacovigilance Practice (GVP)

System Gap Identification & Analysis

Our experts perform thorough gap analyses to pinpoint areas for improvement and provide actionable recommendations to optimize your pharmacovigilance operations. Here are some key requisites for developing a strategic gap analysis plan:

PV System & Process Audits

We pride ourselves on these unique strengths, ensuring that our clients consistently achieve successful audits. By combining proactive strategies, advanced technology, and a commitment to continuous improvement, we provide support in navigating the complex landscape of Pharmacovigilance compliance.

Our team has key USPs that sets our team apart in ensuring successful audits in Pharmacovigilance practices:

• Proactive Monitoring and Predictive Analysis
• Continuous Training and Development
• Customized Audit Preparation Plans
• Robust Quality Management Systems (QMS)
• Cross-Functional Collaboration

Mastering Pharmacovigilance Audits with a Risk-Based Approach

• Risk-Based Audits: Our risk-based approach employs techniques to identify risk areas, where risk is defined as the likelihood of an eventoccurring that could impact the achievement of objectives, considering both the severity of its outcome and the probability of it going undetected by other methods. This audit approach prioritizes the highest-risk areas within the organization’s Pharmacovigilance system, including the quality system for Pharmacovigilance activities.
• System Audits: In-depth evaluations of all relevant verticals, such as PV (Pharmacovigilance), QA (Quality Assurance), IT, and others, encompassing areas safety medical information, case processing, signal detection, risk management, and aggregate reporting.
• Supplier or Vendor Audit: Assessment of the vendor’s processes, Pharmacovigilance systems, software, and compliance with agreements and guidelines.
• Business Partner Audit: Audit of the client’s business partner (SDEA/PVA)/affiliates’ Pharmacovigilance systems and software according to agreements and guidelines.

Merger & Acquisition Diligence Support

Our team offers specialized support to assess the Pharmacovigilance systems of potential acquisition targets, ensuring that all safety and compliance aspects are thoroughly evaluated and integrated.

• Identifying Key Areas:Determining critical areas of the Pharmacovigilance system that need evaluation, such as case management, signal detection, risk management etc.
• Reviewing Regulatory Filings:Examining the target company’s regulatory filings, approvals, and compliance history to identify any potential regulatory gaps or non-compliance issues
• Facility Inspections: Conducting on-site audits of the target company’s facilities to ensure they meet regulatory requirements and are well-maintained
• Checking System Compatibility:Ensuring both companies’ Pharmacovigilance systems & technologies are compatible
• Engaging Key Stakeholders: Maintaining transparent communication with authorities, employees, and partners

PVQA Consultancy

Our team of PVQA (Pharmacovigilance Quality Assurance) experts, alongside our PV (Pharmacovigilance) Subject Matter Experts (SMEs), offer holistic consultancy services. We provide solutions that encompass every aspect of pharmacovigilance, ensuring your processes are efficient, compliant, and optimized for success. Our consultancy approach is comprehensive, combining deep industry knowledge with practical insights to support your pharmacovigilance needs effectively.

• Risk-based Audit Planning (strategic, tactical and operational)
• Audit Program Management
• Inspection Readiness Training
• Mock Inspection
• QMS Development
• IT CSV (Computer System Validation) Management