Quality Management Overview.
Quality Assurance and Compliance Management starts here.
Everything you need.
Arriello offers a wide range of Quality Assurance and Compliance Management services to suit your individual organization. Excellent Quality management is critical to compliance and a successful regulatory inspection.
With Arriello you can trust that we will look after your QMS and provide full oversight required to ensure we create a partnership approach.
Quality doesn’t happen by accident, it’s built in.
Ensuring a faster, better, smarter outcome starts with a deep commitment to excellence.
Discover how our quality-driven culture impacts our quality assurance and compliance management services.
Client focused.
In this video, Tibisay Estupiñan, Arriello’s Quality and Compliance Manager, talks about our quality management approach, our system, and how that connects all services to provides focus on excellence and customer satisfaction.
Arriello’s Quality Management System has been developed to ensure global compliance whilst focusing on you, our customers. A robust, proven and certified QMS underpins all of our services and is embedded in our organizational strategy.
A true Quality Management service.
What Quality Management means for You.
Experience what it’s like to work with an organization that achieves the right goals…the right way. Partnering with Arriello means carefully selected employees, experienced and validated vendors, and continuously improved processes.
Let our experienced staff help you Implement quality management best practices and systems that keep you compliant and improve all your processes…faster, better, smarter.
Our mission for your organization.
Whatever the size of your organization, our mission remains the same.
We’re here to listen to your needs, monitor for the latest developments, and leverage our knowledge to deliver excellence in our quality and compliance consulting and auditing services.
ISO: 9001 Certification.
Helping your organization improve its quality management starts with us.
We’re fully ISO 9001 certified and focus all those best practices and knowledge, gained through years of successful inspections and approvals, on meeting your requirements.
The rewards of improved Quality Management.
With Arriello, you’ll quickly notice the impact of closing gaps in your quality system and processes. Enter an inspection prepared, and confident there’s no question marks over your Marketing Authorization.
Put simply, improving your Quality Management helps you face the future and plan with confidence.
Quality by the numbers.
Our track record speaks for itself.
Check out the number of audits and inspections we’ve experienced over just the last 3 years (figures taken retrospectively at 6 monthly intervals).
The Arriello guide to pharmacovigilance audit success.
When EU legislation on pharmacovigilance came into force in July 2012, it established the clear legal requirement that marketing authorisation holders must perform audits of their pharmacovigilance systems, including risk-based audits of their quality systems.
So why then are so many life sciences companies struggling with associated audits and inspections?
We’ve created a free to download guide that summarizes the 10 aspects of PV covered by the formal requirements, where companies are falling short and where they need to focus their attention to stay on the right side of inspectors.
I see audits as an opportunity to learn, share and improve pharmacovigilance systems; improving what we do and how we do it. Audits should therefore be viewed for the positive changes they can bring, but first, let’s make sure we don’t fail them, and hopefully this guide will help.
Vanessa Fachada Oliveira
Pharmacovigilance Manager
& EU QPPV.
What our clients say about us.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
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.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.
