Nordic Life Science 1
Your end-to-end pharmacovigilance partner CTC Cli
nical Trial Consultants' pharmacovigilance team offers end-to-end support, covering everything in pharmacovigilance from early clinical development to post-marketing surveillance. Safety database PV system advice Access our validated safety database through full-service CRO projects or as a 12-month subscription as your PV Provider. Tailored solutions include SAE case handling, annual safety reporting, SUSAR Line Listings, aggregated reporting and signal management. Plus, benefit from our digital platform for literature searches. Our Advisory Team assists with building pharmacovigilance systems aligned with your marketing authorization application timeline. Services cover QMS setup and gap analysis, SOP writing, audit/inspection preparation, regulatory compliance, PSMF preparation and QPPV/deputy QPPV roles. Post-marketing pharmacovigilance We offer comprehensive post-marketing surveillance, including QPPV/deputy QPPV roles, medical advisors, signal management, literature services, ICSR handling and medical information services together with product complains. We collaborate with our sister companies RegSmart and RegFile for adjacent services. We are a full-service CRO with an in-house site-network, handling all aspects of clinical trials. Contact us for high-quality, cost-effective pharmacovigilance solutions and clinical trial support! Visit our website: www.ctc-ab.se/services/pharmacovigilance/ Contact email: rfp@ctc-ab.se www.ctc-ab.se