Red Line can ease the regulatory burden and assist you in keeping up to date and compliant with the latest Pharmacovigilance regulatory requirements. We offer EU QPPV support and as QP will oversee the complete Pharmacovigilance process.
We have compiled a set of Pharmacovigilance standard operating procedures, which can be adopted by our clients ‘as is’ or used as a template to produce their own in-house documentation.
Let us manage your registration with Eudravigilance, and handle your E2B reporting of company adverse events. We can also maintain your company product licences on the XEVMPD system. Maintaining both Eudravigilance systems is now a mandatory requirement for all EU marketing authorisation holders
Our team is fully trained in adverse event case handling, full case processing and review of individual case safety reports (ICSRs). We provide follow-up investigation for spontaneous cases and expedite to local authorities and reference member states, depending on the product licence and global marketing status.
We manage the process for the compilation, review and submission of aggregate reports (PSURs, PADERs) for submission to regulatory bodies such as the EMA and the FDA within specific deadlines.
We are proficient in signal detection activities and risk management plans to manage the continuing evaluation of the risk/benefit balance throughout your product’s lifecycle.
We are adaptable and our services are provided using our own in-house systems and software or by accessing the client’s own database remotely, where required.
If you wish to discuss your Pharmacovigilance requirements and how we can support your compliance, please click here.