Did you know that as soon as you apply for a Marketing Authorisation, you should be conducting pharmacovigilance activities?
For both medicinal products and medical devices, we can provide a full pharmacovigilance service designed to meet the complex and changing needs of the global environment, under the direction of a Qualified Person and deputy Qualified Person for Pharmacovigilance.
We can also provide local assistance in any European Union country that requires a local QPPV. We maintain an approved pharmacovigilance system, to which we can add your product. However, if your business needs an individual system, we can design your systems and risk management plans.
We can handle your adverse event reporting and maintain your safety database. We can conduct literature searching, including local territory and languages, on your behalf, identify trends and detect signals. We also perform case assessments and audits for both marketed products and products under development. We write Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR) and Risk Management Plans, and we can supply medical writing services to meet your business requirements.