Conducting proper due diligence is not just important for mitigating risks and ensuring patient safety, it also safeguards your investments and reputation by identifying potential compliance gaps and their implications for your business.
Due diligence in pharmacovigilance (PV) is a critical and comprehensive process undertaken to ensure the safety and efficacy of medicinal products, and their alignment with global regulatory standards and regulations such as EU-GVP, FDA, and other local requirements.
It is also essential for assessing existing the PV systems and processes already in place for company mergers, acquisitions, and licensing agreements.
It requires the meticulous evaluation of the risk-benefit profile of medicinal products, and the effectiveness of the PV systems in place to monitor this alongside all other compliance obligations.
And as the adoption of AI technologies within PV becomes more common, it is important that their integration is also thoroughly reviewed to also assess their alignment with regulations too.
Regulatory Compliance Assessment
We conduct thorough evaluations of PV systems against international regulatory requirements to ensure complete compliance. Our assessments cover all aspects from adverse event reporting to safety data integrity.
PV System and Process Evaluation
Our team assesses your PV systems and processes, including adverse event reporting mechanisms, data analysis practices, and safety communication channels, and identifies sub-standard or inefficient areas that require improvement for compliance or to meet best practices.
Risk Management Plan Review
Our experts analyse your risk management strategies and methodologies to ensure they effectively mitigate safety risks associated with your products.
Safety Data and Documentation Audit
We review the quality, completeness, and management of safety data to guarantee accurate reporting and signal detection - essential for ongoing safety monitoring and regulatory compliance.
Vendor and Partner Due Diligence
We conduct a detailed evaluation of your vendors and partners' PV practices to ensure they adhere to regulatory standards.
Our team has extensive experience within regulatory agencies and other areas of the pharmaceutical industry, giving us a comprehensive understanding of global PV requirements. And we combine that knowledge with our world leading regulatory intelligence platform iViReg for the latest developments and trends in regulations around the world.
The consultative advice we provide from the due diligence process is based on creating value through sustainable best practices, considering and incorporating the best professional information and expertise around safety and regulations.
This, together with our expertise and innovation within technology and AI, allows us to propose and develop solutions that are efficient, compliant, and focused on your business ambitions.
When you entrust iVigee with your pharmacovigilance due diligence needs, you gain a partner that not only protects your operations today, but also ensures you are informed and ready for the challenges, opportunities, and technologies of tomorrow.
Whatever your Due Diligence requirements, our experienced pharmacovigilance team can provide the solution.
