- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
The process of selecting a pharmacovigilance (PV) provider is a pivotal step in ensuring the safety and success of your medicinal products, and our Pre-qualification service is designed to assist you with the decision-making process. We understand the importance of partnering with PV providers who not only meet regulatory standards but also align with your unique business needs and values.
Our approach combines years of regulatory expertise with a deep understanding of the pharmaceutical industry to thoroughly assess and pre-qualify potential providers. With our extensive knowledge of global and local PV requirements, including EU-GVP, FDA regulations, and other relevant standards, we can ensure prospective partners are compliant and capable of delivering the highest level of safety and pharmacovigilance services.
Regulatory Compliance Audit: Conducting detailed audits of PV providers to ensure their consistent compliance with regulatory frameworks and client-specific needs.
Technological Proficiency Testing: Evaluating a provider's use of PV software and technology for regulatory intelligence, adverse event reporting, signal detection, and risk management, ensuring state-of-the-art tools are employed.
Staff Competency Evaluation: Assessing the qualifications, training, and experience of a provider's pharmacovigilance staff, focusing on their ability to meet global regulatory demands.
Process and Procedures Review: Examining a provider's standard operating procedures (SOPs) and workflows for handling pharmacovigilance tasks, ensuring they are robust and efficient.
Audit and Inspection History Analysis: Reviewing a provider's history of regulatory audits and inspections, and analysing the outcomes and corrective and preventive actions implemented to gauge their commitment to continuous improvement.
As industry experts with years of experience, iVigee can offer an unparalleled service pre-qualifying your potential pharmacovigilance providers. Our deep understanding of global pharmacovigilance regulations enables us to conduct thorough compliance evaluations and anticipate regulatory changes that may impact choices.
The evaluation methodology we use guarantees a holistic approach to the entire process beyond compliance, covering a provider’s operational excellence and technological proficiency as well. And as the adoption of AI and other technologies and tools continues at pace, iVigee is uniquely positioned as an industry expert to assess how that technology has been implemented and is being used regarding both efficiency and governance.
Our focus on continuous improvement creates a comprehensive support service for pharmaceutical companies with the choices of partner they make, their current and future needs, and their commitments to compliance and patient safety.