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)

Pharmacovigilance system master file (PSMF)

Since the new EU pharmacovigilance legislation is effective, MAHs have to think of implementing a PSMF. The PSMF comprises several sections describing the pharmacovigilance system that documents the compliance with the new PV requirements.

Aspects as e.g. the organisational structure of the company, information regarding the QPPV, the processing of safety data, the description of the involved computerized systems and databases, and the quality system have to be described.

Besides the preparation, the PSMF has to be continuously maintained in order to stay compliant.

Lindeq offers several solutions, such as preparing, maintaining and storing in the classic way, or with a user friendly web-based hosted solution accessible over the internet at all time.

Contact us for more details regarding our PSMF solutions.