The team is knowledgeable in all elements of PV, enabling them to provide PV services in an efficient, compliant, and standardized manner. Additionally, the IT infrastructure is developed in the form of databases, backup systems, and quality management systems. As a result, the MAH gains access to both experienced personnel and technology and tools that will enable it to provide pharmacovigilance services in an effective and compliant manner.
PV activities of a pharmaceutical or a medical device company are typically intermittent in their intensity. Where PV demand is minimal, the MAH can cut management expenses by outsourcing. Additionally, MAH can achieve cost-effectiveness in such a competitive and demanding business by limiting the number of resources required to recruit, manage, and/or train.
A reputable service provider can supply you with fit-for-purpose safety models and tailor its safety solution to your exact specifications, allowing you to take advantage of the benefits of PV / Safety outsourcing in the EU/EEA.
When a benefit-risk strategy is effectively applied for each product, PV outsourcing can help companies gain a competitive edge by enhancing the product’s safety profile and so achieving their business objectives. Our PV professionals place premium attention on medical and safety outcomes, delivering critical business insights that enable them to make sound business decisions.
If you are a new potential MAH in the MAA process, QPPV outsourcing may be particularly beneficial in obtaining the documents essential to support your application. A good place to start is with a gap analysis to establish which components of the project you can develop in-house and which you should outsource.