Electronic reporting

SUSARs and ICSRs have to be reported electronically (E2B) to EudraVigilance (EV) and/or to all concerned Competent Authorities. Therefore, your company has to be registered with EudraVigilance. Once registered, Lindeq reports your initial and follow up reports that fulfil the criteria for expedited reporting either via our fully validated E2B compliant safety database, or alternatively through the EV Web Trader, the EMA reporting tool for ICSRs and SUSARs.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.

Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
Quality Management System
Web-based quality management system software including training and document management
Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
Full range of cosmetic product safety services for all different types of cosmetic products
Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)