Regulatory and PV
Quality and Compliance

Implement quality management best practices and systems that keep you compliant and improve all your processes...faster, better, smarter.

arriello_regulatory affairs and pharmacovigilance quality and compliance

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 Regulatory and Pharmacovigilance quality and compliance services.

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, trained vendors, and continuously improved processes.

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 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 audit 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 audit inspection prepared...ensure there’s no question marks over your Marketing Authorization. Put simply, improving your Quality Management helps you face the future and plan with confidence.

"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." Dr. Michael Lange Managing Director, Sintetica GmbH, Germany

Dr. Michael Lange
Managing Director, Sintetica GmbH, Germany

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 2 years.

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Successful client audits
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Successful Regulatory Agency audits
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Completed vendor audits
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Internal audits

Quality Management Services

Quality System Audit

Measure your systems and processes against industry best practices.
With a Quality System Audit, we’ll audit your organization’s Quality Management System and processes, and identify the issues that need improvement. And of course, we’ll leverage all the experience we gain from being regularly audited ourselves.

Quality System + PV Audit

Take your quality system audit to the next level.
With this service, we’ll look at your QMS and your pharmacovigilance system together. Go beyond an evaluation of your organizational processes and discover if your company follows Good Pharmacovigilance Practices (GVP). We’ll examine all your procedures to ensure you’re compliant, and your patients are safe.

Full Audit Report

Whether you choose just an audit of your QMS or to dive deeper to include your pharmacovigilance system, we summarize our analysis, your gaps and recommendations in a detailed report.
Most importantly, you’ll walk away knowing what steps to take next, and should you wish, you can select any combination of our services below to craft the solution you need.

Build a Quality Management System

Let us create a system for you that will keep you compliant, meet your objectives, and mitigate your risks.

Whether your QMS has gaps or is entirely absent, we’ll help you establish a fully functioning system to industry best practices.

Hire a Quality Auditor

The gaps and issues identified through the audit process will generate a series of CAPA’s - Corrective Action/Protective Actions that are required. You can hire one of Arriello’s Quality Auditors to work with you in implementing these CAPA changes to update your system and processes.

Prepare for Your PV Audit Inspection

A pharmacovigilance audit inspection can be nerve wracking and have widespread consequences if there are problems.

We’ll help you understand what’s required, when it’s required, and we’ll train your team and/or provide all the support you need during the audit.

A culture of quality

Olga Vorobyeva, Arriello's Quality Manager explains the importance of quality management to the Arriello team and how an embedded quality culture is critical to our success.

 

"Our faster, better, smarter approach to all the work we do meant we needed to follow a proven and globally recognized quality standard, and this is why we chose to become fully ISO: 9001 certified and embed this into our practices and culture.

We work exceptionally hard to maintain this system and it underpins all the work we deliver clients. It’s a key part of why they love what we do and why we’ve become a trusted partner to them. "

Arriello Quality and Compliance services - Olga Vorobyeva

Olga Vorobyeva
Quality Manager

Are you facing a compliance inspection?
Do your Quality Management systems and processes meet best practices?

Whatever your requirements, you can be sure we have a solution for you.