Good Pharmacovigilance Practice (GVP) is the minimum standard for monitoring the safety of authorised medicinal products in the EU. It is therefore essential that you ensure your internal systems or those of your client meet the required standards. In addition, having an effective system in place from the start will help to identify and resolve any compliance issues in a controlled and cost-effective manner. This not only lessens the chance of urgent remedial actions being required but also helps to avoid inspection findings or ultimately sanctions from the regulators.
How can we help?
Our consultants have all the necessary expertise and experience to complete pharmacovigilance systems audits of facilities anywhere in the world, checking for compliance with the necessary EU GVP standards. We can support marketing authorisation holders to ensure that there is an adequate and effective quality system in place for monitoring the medicines they have licences for. We are also able to advise on the implementation and tracking of Corrective and Preventative Actions (CAPAs) and carrying out the required updates to the pharmacovigilance system master file.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION