Global Pharmacovigilance Services

Supporting our customers through all stages of the product life-cycle

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QVigilance offers a fully compliant and high-quality complete
package of pharmacovigilance and materiovigilance services,
tailored to meet your specific needs.

Our Pharmacovigilance Expertise

Safety Database

QVigilance offers set up and hosting of AB Cube SafetyEasy Database, which avoids the cost and delay of setting up a compliant safety processing system in-house.

Case Processing & Reporting

Case processing is performed by qualified and highly trained pharmacovigilance staff following clear and comprehensive internal procedures and using our validated Argus 8.1 database.

Aggregate Reports

The periodic reporting of aggregate safety reports provides National Competent Authorities with a comprehensive safety profile overview of a drug based on the collated evidence to date.

Literature Screening

We run a medical literature search for specific purposes or for ongoing screening of worldwide literature as required by local and regional requirements.

Risk Management

Our PV team includes medical writers and physicians who are experts in the authoring, review and update of Risk Management Plans for generic, innovator and advanced therapy medicinal products.

Medical Device Vigilance

QVigilance provides a full range of Materiovigilance (MV) services in support of both device clinical studies and post-registration needs.

Regulatory Intelligence

Our team continuously monitors regulatory information from local, regional and global authorities for PV-related regulatory intelligence to ensure our customers are up to speed and maintain compliance.

Signal Management

QVigilance procedures on ongoing periodic Signal Detection & Management are written in accordance with GVP: Module IX, and is applied to products both pre- and post-authorisation.

Pharmacovigilance Consultancy

We can provide guidance and support in the development of SOPs/working practices supporting pharmacovigilance activities where these are undertaken within your organisation.

Choose QVigilance as your trusted PV partner!

DO YOU NEED SUPPORT FOR YOUR PV SYSTEM?

Choose QVigilance as your trusted PV partner!

Learn how our Pharmacovigilance Services can ensure patient safety and complaint systems!