Regulatory Intelligence.
Knowledge is power.
Local regulatory intelligence is one of the essential requirements of an effective regulatory strategy and is incredibly valuable for anticipating change.
Knowing where to search and what to look for is not sufficient, which is why we obtain and maintain a wealth of information related to submission procedures, MAH responsibilities, GxP requirements and regulatory fees.
Our experts stay one step ahead through our global network of trusted partners to keep fully up to date on any changes that could positively or negatively affect your products.
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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.