We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). Our pharmacovigilance consultants have significant experience of working with companies all over the world.
As a company that works with a global client base, we handle a wide range of pharmacovigilance related issues for client companies. Some of the most frequently requested services that we offer are detailed below. However, if our pharmacovigilance consultants, headed by Natasha Daly, can assist you, then please get in touch with us.
Do you require a Qualified Person for Pharmacovigilance (QPPV)?
We can help you fulfil this requirement, offering round the clock availability of a Qualified Person for Pharmacovigilance (QPPV) services. Our dedicated Pharmacovigilance team are ready to act as your QPPV or deputy QPPV and manage the ongoing safety evaluation of your products, which is flexible to suit your budget.
Electronic Reporting & Eudravigilance
We have established procedures for the collection, management and medical evaluation of all case safety reports, including product complaints and medical information queries. We ensure 100% compliance with reporting timelines in relation to the reporting of adverse reactions as individual case safety reports (ICSR) to Eudravigilance and the Competent Authorities while keeping you informed.
Through the expertise of our pharmacovigilance team and medical experts, our signal management process covers all activities from signal detection and analysis to signal assessment and recommending action where appropriate.
Our experienced team of pharmacovigilance auditors can address the specific demands of the PV legislation by conducting risk based systems audits of the PV system, 3rd party service providers and distributors. We offer very competitive rates for PV auditing, contact us today for a quote.
MAHs in Europe must ensure that all personnel involved in the performance of pharmacovigilance activities receive initial and continued training. Training plans and records must be maintained for documenting and developing the competencies of personnel. Our team of experts can provide pharmacovigilance training face-to-face or via webex, thus ensuring you have the fundamental skills to do your job and avoid audit findings.
Get in touch with us today by calling 00353 52 61 76706 or completing your details below.