Pharmacovigilance & Drug Safety
Do you require flexible pharmacovigilance services throughout a product’s lifecycle? QbD Group offers services for products during clinical trials, marketing authorization application (MAA), and post-marketing phase.
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
Pharmacovigilance encompasses the scientific and systematic processes involved in identifying, evaluating, understanding, and preventing adverse reactions or other potential issues related to drug use.
Our Pharmacovigilance services enhance patient care and safety with respect to medication use. We continuously evaluate the benefit-risk profile of drugs, ensuring patients are safeguarded from avoidable harm.
Our offerings include:
- Use our PV quality management system with a simple “bolt-on” via a PV agreement
- Creation of PV agreement
- Production and maintenance of Safety Data Exchange Agreements between QbD and Clients / Sponsors
- • Serious Adverse Event (SAE) processing/reporting
- Communication with Sponsors / Applicant / Marketing Authorization Holder (MAH) for the exchange of safety information.
- Submission of SUSARs to relevant competent authorities and Ethics Committee (EC)
- Development Safety Update Reports (DSUR)
- Creation of an annual review and evaluation of a product including the submission to relevant authorities/EC.
- Pharmacovigilance System Master File (PSMF)
- Preparation and maintenance of the PSMF and summary of the PSMF
- Qualified Person for Pharmacovigilance (QPPV)
- Risk Management Plan
- Preparation and maintenance of the RMP
- ADR processing / reporting
- In-house E2B-compliant PV database
- Experience with EudraVigilance for the purpose of submitting ICSRs
- Periodic safety update reports (PSUR)
- Preparation and submission of PSUR in the required periodicity on behalf of an MAH for a medicinal product
- Literature search
- Conduct local weekly literature searches using PubMed
- L2A and MLM weekly searches using EVWeb
- PV Intelligence Reports
- Monthly PV intelligence searches covering relevant PV information for clinical trials and post-marketed products
Why opt for the QbD Group?
Our PV team offers extensive pharmacovigilance knowledge and expertise to support the client’s needs in an efficient and pragmatic manner.
We support pharmacovigilance activities required throughout a product’s lifecycle i.e. during clinical development, at the time of marketing authorization application, and following approval.
QbD is able to offer a bespoke service to the client in which they are able to tailor the pharmacovigilance requirements to the client’s needs.
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.
