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)

Electronic pharmacovigilance system master file (PSMF)

The EU pharmacovigilance legislation from 2012 requires a pharmacovigilance system master file (PSMF) to describe the marketing authorisation holder's pharmacovigilance system and document its compliance.

Lindeq provides a time saving, fully compliant electronic PSMF solution: we establish and maintain the PSMF in a web based system. By this the PSMF is available at all time, from any location with internet access. All documents are clearly arranged in accordance with the GVP and updated with version control and full traceability of document changes. With only one click updates compared to any previous document are visible. Restricted access ensures appropriate control over the PSMF as requested by the authorities. Additionally, the PSMF is easy available on request by the EMA or the national competent authorities.

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