About QVigilance
WHO WE ARE
Global Pharmacovigilance Service Provider
QVigilance is Quanticate’ sister company specialized in providing comprehensive pharmacovigilance (PV) and risk management services for Sponsors of clinical trials and Marketing Authorisation Holders
“We strive to exceed our customers’ expectations and ensure our customers remain compliant with local, regional and global regulatory requirements and guidelines”
Adept in supporting customers transitioning from clinical trials to post-marketing and establishing a compliant pharmacovigilance system to support our customers’ products.
We are committed to delivering quality-driven pharmacovigilance services and working collaboratively and flexibly with our customers. Together, we work towards continuous improvement in our understanding of
Corporate Values
Quality Driven
Striving to continuously meet regulatory requirements and exceed the expectations of our customers through careful planning and robust quality control practices
Robust Processes
Solutions underpinned by comprehensive inspection-ready procedures maintained within an audit-trailed quality management system
Tailored Solutions
Flexible services to meet the specific vigilance needs and integrate seamlessly with our customer’s company structure, systems and processes
Collaborative Partnerships
Sharing common standards and goals with our customers and working with openness, transparency and accountability to ensure mutual respect and satisfaction
Agile Team
Maintaining an experienced and adaptable team kept up to date with the latest requirements capable of taking on challenging projects and solving complex problems
Proactive Improvement
Continuously drawing on our expertise and feedback from our customers to ensure our people, systems and processes deliver high quality, effective and efficient services
Our Pharmacovigilance Expertise
Clinical Trial Pharmacovigilance
We cover product safety right through the development cycle ensuring that ICH Good Clinical Practices are met. Our teams are experts in clinical trial safety including SAE case handling and periodic report production. We pride ourselves on our ability to work with multiple CROs, sites
Post-authorisation Pharmacovigilance
Our objective is to ensure the continuous monitoring and improvement in our understanding of the risk-benefit profile of our customers’ products. We are committed to establishing and maintaining a fully compliant PV system throughout the product lifecycle and thereby safeguarding patients.
Medical Device Vigilance
Our materiovigilance services are fully comprehensive and cover both clinical studies and post-registration needs for devices. We are experienced in the different requirements for EU CE-marked devices as well as non-EU, non-CE marked products, Implantable Medical Devices, In Vitro Diagnostic Medical Devices and drug-device combination products following both European Union (EU) MEDDEV guidelines and relevant parts of subsection H on Medical Devices under FDA CFR 21.
OUR GOAL
To help our customers ensure patient safety by:
- Regulatory Compliance
- Complying with regulatory requirements and standards globally
- Global Vigilance System
- Setup and managing an effective and efficient global vigilance system
- Benefit-Risk Managment
- Continuously improving the understanding of benefit-risk profile of products
- Tailored Support
- Providing outsourcing support and expertise for individual vigilance activities
QVigilance Timeline
Our Pharmacovigilance team was established and our Safety Database hosting solution went live with the implementation of Argus 5.1
The new eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) supported
Ongoing and periodic signal detection and risk management procedures were implemented in accordance with Good Pharmacovigilance Practices (GVP)
The Pharmacovigilance System Master File is a legal requirement for any medicinal product authorised in the EU. The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that the MAH’s Pharmacovigilance system is compliant with EU requirements
QVigilance can monitor and review the Eudravigilance Medical Literature Monitoring (MLM) service, maintained by the EMA, for ICSRs identified in the literature if the customer’s product is included in the list of active substances covered by the MLM service
The ISO 9001 is the internationally recognised Quality Management System (QMS) standard certification designed to be a tool for continually improve, streamline operations and reduce costs.
QVigilance continuously monitors regulatory information from local, regional and global authorities and organisations for PV-related regulatory intelligence to ensure that we and our customers are always up to speed and thereby maintain compliance with the latest regulatory
requirements
Version 8.1 we currently use offers a complete safety database solution, its main features
Available 24/7, ESMS provides medical information enquiry handling for authorised products that are tailored to suit the specific needs of each client and their product(s). Our partnership with ESMS ensures that Medical Information is provided as it would be from a client’s own medical information department.
QVigilance can monitor the EudraVigilance Data Analysis System to the extent of MAH access and download electronic Reaction Monitoring Reports and