Eudravigilance Registration. Now a mandatory requirement, the Redline team assists clients to register with the Eudravigilance Portal, report suspect adverse reactions within regulatory time frames and carry out the registration and submission of up-to-date information on all company product licenses to the XEVMPD.
- Pharmacovigilance Services. Our company is knowledgeable about legislative requirements and proficient in all pharmacovigilance functions, from EU QPPV support and PSUR production to lower level activities such as ASPR, spontaneous case processing and expedited reporting.
- Medical Information Services. We provide a full range of scientific services, from general enquiry handling to assisting with technical clinical responses, product information packs and other clinical information for distribution to the healthcare sector. Our enquiry handling support can be provided out of hours, ad-hoc, short term or as a long term contract.
- Literature Monitoring. Weekly literature product searches and retrospective searches can be managed from our centre as an added service to any of the above activities or to provide support to an existing Pharmacovigilance department.
- Medical Device Vigilance. Full risk management support for the collection, triage, investigation and reporting of incidents related to medical devices, together with trend and impact assessments and liaison with regulatory authorities.
- Training. We provide a range of training options in support of your Medical Information and Pharmacovigilance operations and systems. Training will be tailored to suit your staff requirements and CPD requirements.
- External Audits. External CAPA (Corrective & Preventative Actions) Audits can be requested to review your company or your current provider of Medical Information handling and Pharmacovigilance functions.
A range of services to support the pharmacovigilance process.