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 QPPV support and as QPPV will oversee the complete Pharmacovigilance process.
Our team is fully trained in adverse event case handling, full case processing. MedDRA coding and review of individual case safety reports (ICSRs). We provide follow-up investigation for spontaneous cases and expedite to local authorities, 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.