Pharmacovigilance & Drug Safety
The QbD Group provides strategic and operational support for partial or full outsourcing of Pharmacovigilance (PV) responsibilities.
Our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Our flexible PV solutions activities meet needs from early development to post-marketing of medicinal products.
Our Pharmacovigilance & Drug Safety Solutions
- EU-QPPV and deputy
- UK-QPPV and deputy
- Local-QPPV and deputy
- Pharmacovigilance System Master File (PSMF)
- Standard Operating Procedures (SOP)
- Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEAs)
- PV Compliance: Metric and KPIs
- PV Audits Supporting during Health Agency inspections
- PSUR/PBRER
- RMP
- DSUR
- ACO
- Signal detection reports
- Medical Literature Monitoring (MLM) service
- Global Literature Monitoring in global databases (PubMed, EMBASE)
- Local Literature Monitoring in non-indexed scientific journals
- SAE/SUSAR during clinical trials
- ICSR on market products
- global and validates safety database
- Registration of “New organisation” as non-sponsor
- Registration of responsible person (RP) of pharmacovigilance
- In house and online training
- Annual and onboarding personnel training
- Azierta Academy – Online training platform with tailor-made training courses
Why opt for the QbD Group?
Multidisciplinary scientific knowledge
The QbD Group has a team of experts from diverse scientific backgrounds. This allows us to provide a comprehensive approach to pharmacovigilance and ensures that we can tackle any challenge that comes our way.
Digital innovation
We leverage the latest digital tools and technologies to streamline pharmacovigilance processes and ensure that our clients receive timely, accurate, and reliable data. Our use of digital platforms also enables us to provide real-time reporting and analytics, which can be invaluable in identifying potential risks and opportunities.
Go-to-market models
At the QbD Group, we understand that different products require different approaches. That’s why we offer a range of go-to-market models, including direct-to-consumer, pharmacy, and healthcare provider models. Our team works closely with our clients to determine the best approach for their specific needs.
Global approach with local support
With offices and teams around the world, the QbD Group is well-equipped to handle global pharmacovigilance challenges. However, we also understand the importance of local knowledge and support. That’s why we have local experts in each of our locations who can provide tailored support to our clients.
Support throughout the value chain
At the QbD Group, we provide pharmacovigilance support throughout the entire product lifecycle, from development to post-marketing. This ensures that our clients receive a comprehensive and consistent approach to pharmacovigilance at every stage.
Global offering
The QbD Group offers a full range of pharmacovigilance services, including signal detection, risk management, regulatory compliance, and more. Our global offering ensures that our clients have access to the services they need, no matter where they are in the world.
In short
At the QbD Group, we combine multidisciplinary scientific knowledge, digital innovation, go-to-market models, global approach with local support, support throughout the value chain, and a global offering to provide exceptional pharmacovigilance services to our clients. Contact us today to learn more about how we can help you meet your pharmacovigilance needs.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
