Medical assessment of SAEs and SUSARs

Lindeq provides coverage on medical safety management. We have protocols in place that will perform all necessary steps covering SAE and SUSAR: Receipt and acknowledgement, triage and assessment, data-entry, MedDRA coding, narrative writing, analysis with medical review, assessment and quality control. We also deliver expedited reporting to regulatory authorities as well as AE/SAE reconciliation. Our team consists of experienced medical doctors and pharmacists that can provide reliable assessments of any safety issue that might arise.

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)