QPPV Support

All Market Authorisation Holders are required to have a Qualified Person responsible for pharmacovigilance in the EEA. The QPPV must be experienced in all aspects of pharmacovigilance, live in the EEA and be available 24/7/365.

We offer fully experienced physicians/HCPs to act as the QPPV or deputy settled in EEA and who can well support clients to meet their QPPV need.

We also offer the services for countries where local contact for pharmacovigilance is the requirement.

PSMF Writing and Maintaince

We at Clini Resource completely understand the requirement and need of PSMF in EU and countries where similar document is required either electronic or manual.

We offer preparation, review and maintenance of PV System Master File (PSMF) with complete Annexures in compliance with EU guidelines or local regulatory guidelines.

We do this for clients whether or not we provide the pharmacovigilance service.

In-house/On-site Pharmacovigilance system development

For clients that wish to establish their own in-house PV system, we offer assistance in terms of corporate training, recruitment and complete standard operation procedure (SOP) preparation.

We also offer trained executives that can work on the client's site for specific projects.