Pharmacovigilance

Pharmacovigilance Services

The growing importance of pharmacovigilance (PV) can sometimes be perceived as a burden to pharmaceutical companies, who are ultimately responsible for drug safety and ensuring compliance with constantly evolving international regulations.

Meeting the challenges of monitoring medical drug effects in-house can put pressure on time and resources. The slightest error in the pharmacovigilance reporting procedures can have costly and adverse consequences, not to mention their effect on patient health. Outsourcing these activities to a specialised and compliant pharmacovigilance consultancy firm is a flexible solution to the constant demands of maintaining an in-house operation.

At BlueReg, our dynamic and adaptable team will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.

ADVICE

Risk management & PV case processing

We support safety data collection and reporting of individual case safety reports (ICSRs) in accordance with good pharmacovigilance practices (GVP) on a broad portfolio of products, reference and generic medicines in all therapeutic areas. Our pharmacovigilance team provides comprehensive global safety and medical services, including safety case management, medical safety and writing (DSUR/PSUR-PBRER), signal detection and surveillance. We assist pharmaceutical and biotech companies to maximize product performance by managing risk before, during, and after marketing authorisation.

Pharmacovigilance organisation and system

We provide advice on the organisation of your in-house pharmacovigilance department and setting up a PV system. We can support with the preparation of the Pharmacovigilance System Master File (PSMF) and associated documentation (SOPs and SDEA).

 

Moreover, BlueReg can conduct PV audits according to your needs and GVP to identify potential issues or deficiencies at different stages of your safety processes. Our experts provide advice and solutions to resolve compliance issues in a cost-effective and structured manner prior to PV inspections by regulatory authorities ensuring that you can experience these with confidence.

Qualified Person for Pharmacovigilance QPPV

BlueReg can provide an EU Qualified Person for Pharmacovigilance (QPPV), a local QPPV (France) and/or Deputy with extensive knowledge and experience of the pharmaceutical industry to meet your evolving needs.

 

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