How we can support patient safety
Auditing
Vigilance experts allocation
Operations
Audit presents an on-site verification of compliance with specific requirements.
It can apply to an entire organization or be specific to a function, process, or production step.
Same as for any audit, PV audits have their specifics, such as auditing PV documents, relevant risks, or following up on completed corrective & preventive actions.
Our extended team can support you with PV system audits.
Operations
Vigilance experts allocation
Operations
Operational Vigilance activities are related to interactions with EudarVigilance & EUDAMED databases, for medicinal products & medical devices, respectively.
This correspondence should go smoothly, however it is critical to perform timely submissions as per PV legislation.
Our extended team can support you with both databases interactions and project management of all relevant PV interactions,
Vigilance experts allocation
Vigilance experts allocation
Vigilance experts allocation
Our extended team consists of safety experts, experienced in clinical safety and vigilance, including QPPV.
The QPPV is specifically responsible for establishing and maintaining the company's PV system, overview of the safety profiles, and any emerging safety concerns for the company's drugs and acting as a single contact point for the Hea
Our extended team consists of safety experts, experienced in clinical safety and vigilance, including QPPV.
The QPPV is specifically responsible for establishing and maintaining the company's PV system, overview of the safety profiles, and any emerging safety concerns for the company's drugs and acting as a single contact point for the Health Authorities on a 24-hour basis.
Our extended team can be of huge help.