Arriello

Everything you need

Our global services span the product life cycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions. Valued clients rely on our ability to deliver, however complex their requirements, through our proven expertise, global coverage, and technology.

Why choose us

Whatever stage you’re at, and wherever you need us to be, we have the right Pharmacovigilance, Regulatory, and Quality and Auditing services and solution for your needs. We aim to be your partner of choice for your journey to market, and throughout the life cycle of your products. Our ability to provide a tailored, focused small-company service, allied to the ability to help drive large projects with scale and footprint is unmatched in the industry.

With you for the long run

Nobody else is better positioned than Arriello to provide the personalized and attentive service needed for all your requirements across the product life cycle.

Making lighter work of finished product manufacturing site transfer variations in life sciences

Recognizing the needs of pharma supply chains

Arriello is at the forefront of ICH Q12/PACMP-based finished product manufacturing site transfer variations management. Over the two years to March 2023, we catered for up to 50 finished product manufacturing site transfer variations, both national and MRP applications, with submissions successfully performed across the EU and Eastern Europe deriving from our own experience the features of both the traditional and PACMP approaches.

Here we had the opportunity to work with a range of pharmaceutical forms, and generic products, well-established use medications, as well as standalone applications. Specific new measures under International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guideline Q12 include the Post-Approval Change Management Protocol (PACMP).

The project team has been fantastic to work with from the initial onboarding/transition continuing through daily maintenance. In particular, I really appreciate that when I send a request to Ines, I do not need to follow up repeatedly or request status updates – everything is simply taken care of!

International pharmacovigilance leader, Boston biotech

Vendor selection and management: maintaining a robust safety profile through tighter supplier controls

Quality without boundaries

Throughout the drug authorization process and right across the marketing authorization lifecycle, license holders are responsible for ensuring the continuous monitoring of the safety profile of a medicinal product. This includes accountability for all third parties and contractors with a potential impact on that safety profile. These might be vendors, contractors, service providers, or consultants.

Relevant suppliers could include anyone from local distributors or qualified persons to IT system partners, security providers and even auditors themselves. Arriello is unique in the market thanks to the end-to-end scope of our offering.

We can manage and maintain PV agreements (vendor contracts); manage and check on vendors’ evolving status and details; work with you to create your audit strategy; and perform audits or run your audit program. We can also offer CAPA management and consultancy advice on QMS/VMS best practices.

My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.

Peter Patrick O’Donnel, lPV Project Manager, Aspen Pharma Trading Limited, Ireland

Read more about how Arriello can help you with our downloadable guide