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Pharmacovigilance and Drug Safety
Our EMA, FDA and ICH compliant pharmacovigilance (PV) solutions enable bio/pharmaceutical companies to meet their clinical and post-marketing PV obligations in a robust, cost-effective and compliant manner.
Using our experience, expertise and intimate knowledge of the internal workings of PV and regulatory agencies and workgroups, we’re able to ensure you remain compliant.
Our PV cloud service gives you a simple yet transparent approach to undertaking PV electronic reporting in a manner that meets the needs of regulatory authorities. Our full service provision includes a PV system, appropriately qualified personnel plus database. Alternatively we can combine modified elements of the system to match your exact requirement.
Our drug safety and pharmacovigilance services are complemented by several of our other practice areas, including:
* Pharmacoepidemiology and Risk Management
* Clinical and Medical Services