ONE-Vigilance
QbD offers a set of services globally called One Vigilance, which will distinguish us in the Health Sciences Consulting sector.
ONE·VIGILANCE, QbD Group’s solution, emphasizes safety as a revenue-generating activity, offering a comprehensive approach with global expertise. The ‘glocal’ solution integrates scientific methodologies, proprietary tools, and a team of experts in pharmacovigilance, biopharmacovigilance, and medical devices vigilance. Efficient regulatory compliance and valuable insights enhance product marketing and trust with prescribers and patients.
This service meets the needs and obligations of the MAH surveillance team to comply with current legislation.
Our ONE-Vigilance services
Global Assessment in ONE-Vigilance
Do you need a global and comprehensive surveillance service to take care of the safety profile of your products from the beginning to the end of your product’s journey, and especially of the entire value chain?
Regulatory Intelligence
Regulatory intelligence includes identifying, collecting and classifying information, especially government agency guidelines and policies in order to be compliant with international/local legislation or identifying any safety measures.
Safety Database Solution
Technological plattform to manage and comunicate all the ICSSr, and to use all the agregate tools to have the best and appropriate PV model from a safety point of view.
Medical Information
QbD offers a set of Medical Information solutions, a distinctive offering in the Health Sciences Consulting sector.
We ensure effective regulatory compliance and valuable information to improve the marketing of products and the confidence of prescribers and patients.
Literature Monitoring Services​
Elevate Your Product Safety Assurance with QbD’s Comprehensive Literature Monitoring Services!
Aggregate Safety Reporting
We offer a set of services globally called One Vigilance, which will distinguish us in the Health Sciences Consulting sector.
Signal Detection Management
The European Medicines Agency (EMA) defines a safety signal as crucial information regarding a potential adverse event associated with a medicine, necessitating further investigation.
At QbD Group, we understand the complexities of managing Pharmacovigilance (PV) responsibilities across multiple territories. Whether you are an MAH in Europe, the UK, or globally, our services cater to your specific needs.
Pharmacovigilance Training
With QbD Group can elevate your compliance standards with our tailor-made courses, online training platform, and over a decade of proven experience.
PV Audits & Inspections: Quality system management in Pharmacovigilance
At QbD Group, we recognize the critical need for a robust quality and safety framework, and our comprehensive services are designed to address every facet of this obligation.
EudraVigilance
EudraVigilance Registration for the electronic exchange of pharmacovigilance information data being a prerequisite for electronic reporting.
Â
Do you need to perform a timely collection and processing of safety case reports? We take care of it through our global and validated reporting platform ONE VIGILANCE.
Why QBD Group?
QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.
With more than 10 years providing PV services and more than 450 experts. Our experience ensures optimal compliance with national and international PV regulations.Â
10+ years of experience
Full life cycle support
Global presence
Best Managed Company
Contact us
Need help with your Vigilance? Don’t hesitate to get in touch.
