Regulatory Intelligence.
What is Regulatory Intelligence in pharmacovigilance?
Regulatory Intelligence in pharmacovigilance refers to the collection and analysis of regulatory information that can have a current or future implication on development or marketed medicinal products and devices.
As the regulatory landscape is constantly changing, knowing what governments and regulatory authorities are changing in areas such as guidance, GxP regulations and standards, submission procedures and MAH responsibilities, and what that might mean for a client’s products, is an essential activity to keep those products compliant in each market.
Our Regulatory Intelligence services?
Our expert team and partner network continually screen for these changes around the world to provide a fast and efficient interpretation and assessment of them for their impact on procedures and strategy as a part of minimizing your risk.
Our well documented and communicated analysis allows our clients to anticipate and respond to these changes in a timely manner and stay one step ahead.
Selected Case Studies.
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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.