Balancing the risks and benefits of a medicinal product requires strict testing and assessment for quality, efficacy and safety before it can be authorised. This process also continues post-marketing authorisation, helping to ensure the medicine continues to be safe and effective. The legislation that governs pharmacovigilance in the EU was revised in 2010 and became applicable in 2012. It is one of the most advanced and comprehensive systems in the world. It now requires that all companies are inspected against strict guidelines and are therefore expected to be fully compliant from the outset.
How can we help?
Our pharmacovigilance team are experts in quality management and GVP requirements. They will help you set up and run a pharmacovigilance system to ensure you are compliant with the relevant legislation. In addition they are able to conduct audits and provide training to check you are compliant and meeting the necessary standards, as well as providing your internal team with the skills to maintain your pharmacovigilance requirements moving forward.
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