As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may […]
In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV. In general, an audit is, a systematic, disciplined, independent and documented process for obtaining evidence […]
We offer a complete and comprehensive pharmacovigilance services to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). We are here to help you with some or all of your pharmacovigilance needs. Do you require a Qualified Person for Pharmacovigilance (QPPV)? European Pharmacovigilance legislation requires all Marketing Authorisation Holders to have permanently […]
It has been a very busy year for the Acorn Regulatory pharmacovigilance team. Over the course of the year we have worked with a large number of companies around the world. Our team has also produced a large number of well received articles about a range of pharmacovigilance issues. Here are the 5 most read […]
Our latest pharmacovigilance e-book looks at PSUR’s, key performance indicators and more. Download the free e-book here.