Regardless whether you apply for a new marketing authorization or you already have a registration in Europe, regulatory authorities and inspectors expect you to have a well functioning system in place that ensures your compliance with all drug safety obligations.
We find for you the best solution for your pharmacovigilance system in Europe, integrating the various components like technical platforms, processes and people into a compliant and efficient system.
We have long standing experience in setting up pharmacovigilance systems within the European Economic Area (EEA), taking into account the most recent developments in this area (e.g., CHMP guidance notes and Volume 9 revision etc).
Our approach has been audited and is well proven to fulfil the regulatory standards.
The analysis would also include an assessment of costs and a comparison of in-house and outsourcing solutions. You would receive a detailed report and step-by-step recommendations for implementation. If required spm² could offer parts or all system modules for a EU compliant pharmacovigilance system.