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Case Studies

Early Access Programs (EAP)

A French cohort ATU example

From "Own Brand Labelling" To "Virtual Manufacturer"

Companies who do not design or manufacture the devices have to use the term "manufacturer".

Pharmacovigilance - Inspection

EUDRAC held a 2-day pharmacovigilance inspection by the German Competent Authority (BfArM).

Pharmacovigilance - Risk Management Plan

Risk Management Plan in revision 2 template

Any Questions?

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Let us know how we can lighten your way to your regulatory success!