Article 57 (xEVMPD).
Managing the details that keep you compliant.
MAHs and Applicants for medicines in the EU must submit information on authorized medicines to the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), also known as the Article 57 database, and keep this information up-to-date.
In addition, every MAH and Applicant must keep its organization details, EU QPPV details, and location of the PSMF updated in the xEVMPD.
We can manage all these requirements for you, keeping your xEVMPD updated and fully compliant.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.