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Primum non nocere. /First, do no harm./


Hippocrates

Essence I Efficiency I Evolution I Entirety

Essence I Efficiency I Evolution I Entirety

Essence I Efficiency I Evolution I Entirety

Essence I Efficiency I Evolution I Entirety

Essence I Efficiency I Evolution I Entirety

Essence I Efficiency I Evolution I Entirety

Patient is the key!

Vigilance is the process and science of monitoring the safety of medicines & medical devices.


Its purpose is to take action to reduce the risks and increase the benefits of the patients' therapy.


It is a key public health function.

Want to learn more! Let us know!

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.

What else we do

We can be your guide through complex global regulatory, quality & sustainability frameworks and support you in reaching your targets.

And how we can further support you
Want our help? Just contact us!

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Indaea OÜ

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