Quality and Compliance Overview.

Consistent, Independent, and Flexible Pharma Solutions.

At Arriello we understand that Quality and Compliance is more than processes and procedures. It is a mindset that translates legislation and requirements into practical frameworks that not only ensure compliance, but also facilitate efficiency, right first time, consistency, and standardization.

From urgent support such as critical investigations to long-term proactive support such as Quality Management System development, Arriello is here to guide you through the dynamic regulatory landscape and industry expectations.

Our expert Quality and Compliance team have proven industry experience in a wide range of Quality roles ensuring they understand the unique opportunities and challenges that arise in Quality and equipping us to provide novel solutions tailored to the unique needs of our clients.

Understanding Your Quality Requirements.

We understand that compliance with quality standards is not always achieved using a one size fits all approach but depends on the stage in the product lifecycle, the product characteristics, the GxP impact and the organization size and structure which is unique to each of our clients.

Drawing on our experience we develop unique solutions based on science, industry best practice and knowledge of the product, manufacturing process and organizational structure. Our highly experienced team is committed to providing best practice consultancy support that meets the complex needs of our clients, from strategic support to an extra pair of hands.

Arriello’s commitment begins with your first contact, prioritizing partnerships with our clients based on trust, quality delivery, integrity, and communication.

Our integrated services encompassing PV, Regulatory Affairs and Quality & Compliance, provides us with a truly holistic view of our client’s challenges and in turn provides us with the opportunity to provide holistic solutions that optimize a products journey to market.

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An Experienced Auditor Pool. Global Coverage.

Our external auditors have on average 15 years experience in GVP and a number are members of RQA.
Trained auditors within large MAH settings to global standards, a number trained by ex-regulatory inspectors.
All our auditors come from PV operational backgrounds and bring with them an in-depth knowledge base.

Each auditor has access to the other pool of auditors as needed and actively share experiences and knowledge in our constant pursuit for improvement.
Arriello’s internal auditors ensure continuity and compliment our external team, giving you the flexibility and choice to match your requirements.

Auditing for different pharmacovigilance legislation around the world.
Our team is fully updated on worldwide legislative requirements and change through our extensive internal regulatory intelligence process.
Our external pool of auditors also share their experience from audits and inspection, to create a truly united global approach.

Where Our Auditors Are Located.

Quality and Compliance Services.

GxP Technical Consulting.

Arriello experts provide scientific and technical support across the GxPs including GMP, GDP, GCP and GVP. Whether it is provision of an objective opinion, resolution of a problem, implementation of QRM or sterility assurance support, we can provide a solution that fits your needs.

This service is especially beneficial when niche expertise is required or at the beginning of a project such as new facility design where augmentation of internal expertise is especially valuable.

Quality Management System.

A Quality Management System that is compliant with requirements but also efficient, scalable and phase appropriate can be a key differentiator for our clients. Design and implementation of a fit for purpose QMS over generic systems reduces redundancy and unnecessary complexity.

Arriello has successfully designed, implemented, and remediated Quality Management Systems that support licenses and authorizations globally and are compliant with the standards relevant to the client such as ISO9001, ISO13485, ICHQ10 and Eudralex Volume 4 Chapter 1 and Volume 9 GVP Module 1.

Commercialization Readiness.

Successfully launching a medicinal product onto the target markets requires collaboration between many disciplines and stakeholders in addition to experience with the local legislation. The requirements of Good Distribution Practice (GDP) must be complied with as they are interpreted locally in addition to ensuring the appropriate licenses and personnel are in place such as the Responsible Person (RP) or Qualified Person (QP).

Arriello is the perfect partner to guide our clients in the identification of compliant and efficient supply chains that comply with GDP and optimize time to market. We can also provide advice on licensing for manufacturing, wholesaling and distribution activities and we can provide contract personnel to fulfill key roles, not only for quality but also across Regulatory and Pharmacovigilance.

GxP Auditing and Inspection Services.

Audits and inspections are essential for the assessment of quality management system effectiveness and to ensure companies are meeting their compliance obligations, reducing risk to the patient, and fostering a culture of continuous improvement. At Arriello we provide invaluable support to clients in preparation for regulatory inspections through provision of gap analysis, inspection readiness training and coaching and mock inspections. With many years of experience with global regulatory authority inspections including FDA, HPRA, MHRA, ANVISA, PMDA and more, we can provide guidance through the preparation process, coordinate or participate in the inspection backroom and provide support with responses to regulatory authority observations.

In addition to our inspection support we also perform audits on behalf of our clients across the GxPs and can provide single audits or coordinate full third-party audit programs. Our audit model provides our clients with an experienced internal audit coordinator, acting as a single point of contact, and access to a global network of proven and experienced auditors. We act as a dynamic extension of your internal resource capabilities, scaling up or down as required while always providing the best quality service.